Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-03-14 @ 9:31 PM
Study NCT ID:
NCT05126459
Status:
COMPLETED
Last Update Posted:
2024-10-02
First Post:
2021-11-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C080042', 'term': 'ICE protocol 3'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JWChen@llu.edu', 'phone': '909 558 1000', 'title': 'Dr. Jung-Wei Chen', 'organization': 'Loma Linda University Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "The dentists providing sedation were trained to evaluate behavior parameters, but there may have been difficulty in quantifying parameters due to experience and assessment subjectivity.\n\nAll dental treatment was performed with physical stabilization devices, which may have potentially altered the ability to evaluate some of the patients' responses. The postoperative phone calls proved challenging due to difficulty reaching the guardians within the 24 hour phone call window period."}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 hours post sedation', 'description': 'Delayed communication with some parents, up to 48 hours post sedation.', 'eventGroups': [{'id': 'EG000', 'title': 'Regimen 1', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen 1: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 7, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Regimen 2', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) -\n\nRegimen #2: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Regimen 3', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen #3: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sleep Disturbance', 'notes': 'Bad dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Aggressive Behavioral Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Upset', 'notes': 'Diarrhea Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Effects', 'notes': 'Snore, difficult to awaken.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal Effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paradoxical Effects', 'notes': 'Hyperactive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen 1: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG001', 'title': 'Regimen 2', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) -\n\nRegimen #2: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG002', 'title': 'Regimen 3', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen #3: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.67', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}, {'value': '2.5500', 'groupId': 'OG002', 'lowerLimit': '2.2', 'upperLimit': '2.9'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'groupDescription': 'Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events during sedation.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'during sedation', 'description': 'Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation.\n\nData will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge Musculoskeletal system reaction during sedation scale: This is the result for Musculoskeletal related questions, it is a sum of 3 yes or no questions. (minimum=0, maximum=3) The higher the worse.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1', 'description': 'Regimen 1: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG001', 'title': 'Regimen 2', 'description': 'Regimen #2: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG002', 'title': 'Regimen 3', 'description': 'Regimen #3: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.88'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.007', 'upperLimit': '0.39'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '0.044', 'upperLimit': '0.44'}]}]}], 'analyses': [{'pValue': '0.211', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'groupDescription': 'Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events at 8 hours after sedation.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change 8 (eight) hours post oral sedation medication administration', 'description': 'Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation.\n\nData will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge.\n\nMusculoskeletal system reaction at 8 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1', 'description': 'Regimen 1: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG001', 'title': 'Regimen 2', 'description': 'Regimen #2: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG002', 'title': 'Regimen 3', 'description': 'Regimen #3: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.005', 'upperLimit': '0.15'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.374', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change between 24 (twenty-four) hours post oral sedation', 'description': 'Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation.\n\nData will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge.\n\nMusculoskeletal system reaction at 24 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1', 'description': 'Regimen 1: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG001', 'title': 'Regimen 2', 'description': 'Regimen #2: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG002', 'title': 'Regimen 3', 'description': 'Regimen #3: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.30'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.15'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Null hypothesis: there is no significant difference in GI reaction between the 3 regimens.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'During sedation', 'description': 'Compare the number and type of adverse effect related gastrointestinal reactions.\n\nData will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge.\n\nGI effect for during sedation score; This is a summary of 3 yes/no questions, Minimum = 0 Maximum =3, the higher means more GI reactions, the worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 8 Hours After Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen 1: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG001', 'title': 'Regimen 2', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) -\n\nRegimen #2: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG002', 'title': 'Regimen 3', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen #3: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.58'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.15'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'groupDescription': 'Null hypothesis: there is no significant difference in GI reaction between the 3 regimens 8 hours after sedation.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 hours after sedation', 'description': 'Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge.\n\nGI effect 8 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 24 Hours After Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen 1: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG001', 'title': 'Regimen 2', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) -\n\nRegimen #2: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'OG002', 'title': 'Regimen 3', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen #3: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.007', 'upperLimit': '0.39'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The threshold for statistical significance was p=0.05.', 'groupDescription': 'Null hypothesis: there is no significant difference in GI reaction between the 3 regimens at 24 hours after sedation.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours after sedation', 'description': 'Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge.\n\nLong term effect for 24 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Regimen 1', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen 1: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'FG001', 'title': 'Regimen 2', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) -\n\nRegimen #2: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'FG002', 'title': 'Regimen 3', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)\n\nRegimen #3: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Regimen 1', 'description': 'Regimen 1: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'BG001', 'title': 'Regimen 2', 'description': 'Regimen #2: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'BG002', 'title': 'Regimen 3', 'description': 'Regimen #3: Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age, month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '65.25', 'spread': '13.09', 'groupId': 'BG000'}, {'value': '65.10', 'spread': '11.87', 'groupId': 'BG001'}, {'value': '60.30', 'spread': '12.2', 'groupId': 'BG002'}, {'value': '63.55', 'spread': '12.42', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Month', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'pediatric dental patient with situational anxiety in dental operatory settings.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-24', 'size': 421240, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-11T23:09', 'hasProtocol': True}, {'date': '2019-10-24', 'size': 234122, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-11T23:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2021-11-08', 'resultsFirstSubmitDate': '2024-01-18', 'studyFirstSubmitQcDate': '2021-11-08', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-09', 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation', 'timeFrame': 'during sedation', 'description': 'Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation.\n\nData will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge Musculoskeletal system reaction during sedation scale: This is the result for Musculoskeletal related questions, it is a sum of 3 yes or no questions. (minimum=0, maximum=3) The higher the worse.'}, {'measure': 'Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours', 'timeFrame': 'Change 8 (eight) hours post oral sedation medication administration', 'description': 'Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation.\n\nData will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge.\n\nMusculoskeletal system reaction at 8 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse.'}, {'measure': 'Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation', 'timeFrame': 'Change between 24 (twenty-four) hours post oral sedation', 'description': 'Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation.\n\nData will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge.\n\nMusculoskeletal system reaction at 24 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse.'}, {'measure': 'Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation', 'timeFrame': 'During sedation', 'description': 'Compare the number and type of adverse effect related gastrointestinal reactions.\n\nData will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge.\n\nGI effect for during sedation score; This is a summary of 3 yes/no questions, Minimum = 0 Maximum =3, the higher means more GI reactions, the worse outcome'}, {'measure': 'Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 8 Hours After Sedation', 'timeFrame': '8 hours after sedation', 'description': 'Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge.\n\nGI effect 8 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome.'}, {'measure': 'Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 24 Hours After Sedation', 'timeFrame': '24 hours after sedation', 'description': 'Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge.\n\nLong term effect for 24 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric', 'Dental'], 'conditions': ['Anxiety, Dental', 'Dental Decay']}, 'descriptionModule': {'briefSummary': 'This study will compare the post sedation events from three different multi-drug oral sedation regimens in order to help pediatric dentists determine the best course of action for their patients and prepare parents appropriately and caution them about the expected effects. Patients will be evaluated for adverse effects within two time periods at 8 and 24 hours post oral sedation procedure using surveys.', 'detailedDescription': "Inclusion criteria included patients of record who were scheduled to undergo oral sedation at Loma Linda University Pediatric Dentistry clinic for dental treatment. Children ages ranged from 3 to 6 years old with no medical issues, ASA-1. The reason for oral sedation was situational anxiety in the dental operatory. Exclusion criteria included children who presented with a history of: (1) acute illness; (2) upper respiratory tract infection within two weeks of treatment; (3) taking any medication within the two weeks prior to scheduled dental treatment; and (4) a body mass index (BMI) greater than the 95th percentile for their age and gender. A total sample of 60 healthy pediatric patients were included in this study with were no gender, race, or ethnic significant difference.\n\nThe included patients were randomly allocated into one of three sedation groups by drawing a concealed folded paper from an opaque randomization bag after obtaining parent consent. All papers that were used in the randomization had the same size and texture. The pediatric dental resident and attending faculty were informed with medication combination once randomized allocation had been made.\n\nThe study groups were as follows: Group 1 received Midazolam (0.5- 0.75 mg/kg), Meperidine (1.5-2.0 mg/kg), and Hydroxyzine (1.5- 2.0 mg/kg), Group 2 received Meperidine (1.5-2 mg/kg) and Hydroxyzine (1.5- 2.0 mg/kg). Group 3 received Midazolam (0.5- 0.75 mg/kg) and Hydroxyzine (1.5- 2mg/kg).\n\nClinical Procedure Calculations based on the child's weight of maximum local anesthetic delivery, oral sedation medication dosages, and reversal agents were completed prior to delivery of medication. The reversal agent used for benzodiazepines was Flumazenil, 0.01mg/Kg with a maximum of 0.2 mg/dose. While the reversal agent for Meperidine was Naloxone, calculated as 0.1 mg/Kg up to 2 mg.\n\nAfter obtaining proper consents, all patients were placed in passive protective stabilization (Joey Board®, Joey Board, Queen Creek, AZ) in the event the child was to become uncooperative and to maintain patient stability during treatment, as coordination could be impaired. Nitrous oxide/Oxygen (N2O/O2) was used in all sedations and administered at a flow rate of four to six L/minute (30-50% N2O/ 10-50% O2) with 100% O2 given for five minutes pre- and postoperatively. All operating dentists followed standard sedation protocol at standard sedation protocol in Loma Linda University Pediatric Dentistry Clinic adapted from the American Academy of Pediatric Dentistry (AAPD) guidelines.8 Routine dental care was provided with local anesthesia with rubber dam or isolite® isolation. Xylocaine (2% lidocaine with 1:100,000 epinephrine) was used for local anesthesia in all cases and did not exceed 4 mg/kg lidocaine. Once AAPD discharge criteria8 were met, the patient was released to the parent. At that time, postoperative care instructions, including emergency contact numbers and recommendation for over-the-counter pain medications, if needed, were provided both verbally and in written form.\n\nThe dentist performing each sedation was asked to complete a detailed questionnaire that provided details about the patient's behavior from the time of drug administration to the time of discharge (Survey 1). In addition, parents received two telephone interviews regarding events that occurred after the sedation session. An investigator conducted all phone interviews. These phone interviews took place at eight hours (Survey 2) and 24 hours (Survey 3) after discharge.\n\nFor all three of the surveys, questions were designed to elucidate patient physical signs and/or behaviors that fell into the following categories: (1) sleep disturbances; (2) gastrointestinal side effects; (3) non-aggressive behavior changes; (4) residual central nervous system alterations; (5) respiratory depression; (6) musculoskeletal effects; (7) physical reactions; (8) existence of a paradoxical reaction; and (9) amnesic effects. Information on the pre-sedation cooperation level and overall effectiveness of the sedation (rated as ineffective, effective, very effective, or overly sedated) were obtained from the procedural sedation record (adopted from AAPD) corresponding to each case."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo oral sedation appointments in Loma Linda University Pediatric dental clinic for operative procedures.\n* Age 3-7 years old, Healthy ( ASA-1 )\n* No gender, race or ethnic restrictions.\n* Reason for conscious oral sedation is situational anxiety in the dental operatory\n\nExclusion Criteria:\n\n* Children with a history of acute illness\n* History upper respiratory tract infection within two weeks of treatment\n* Children taking any medication within the two weeks prior to scheduled dental treatment\n* Sedation within the last six months\n* Body mass index (BMI) greater than the 95th percentile for their age and sex\n* Failing to drink the entire amount of sedation medications dispensed'}, 'identificationModule': {'nctId': 'NCT05126459', 'briefTitle': 'A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients', 'orgStudyIdInfo': {'id': '5190213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Regimen 1', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)', 'interventionNames': ['Combination Product: Regimen 1']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen 2', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) -', 'interventionNames': ['Combination Product: Regimen #2']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen 3', 'description': 'Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)', 'interventionNames': ['Combination Product: Regimen #3']}], 'interventions': [{'name': 'Regimen 1', 'type': 'COMBINATION_PRODUCT', 'description': 'Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.', 'armGroupLabels': ['Regimen 1']}, {'name': 'Regimen #2', 'type': 'COMBINATION_PRODUCT', 'description': 'Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.', 'armGroupLabels': ['Regimen 2']}, {'name': 'Regimen #3', 'type': 'COMBINATION_PRODUCT', 'description': 'Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.', 'armGroupLabels': ['Regimen 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Jung-Wei Chen, DDS,MS,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Director, Pediatric Dentistry', 'investigatorFullName': 'Jung-Wei Chen, DDS, MS, PhD', 'investigatorAffiliation': 'Loma Linda University'}}}}