Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT03938259
Status:
COMPLETED
Last Update Posted:
2024-07-26
First Post:
2019-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Adam.adler@bcm.edu', 'phone': '832-824-5801', 'title': 'Dr. Adam Adler', 'organization': 'Baylor College of Medicine7'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'adverse events were collected only within the study period of ten minutes', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group; Patients Without Obstructive Sleep Apnea', 'description': 'Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients With Known Obstructive Sleep Apnea', 'description': 'Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Respiratory Depression Following Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group; Patients Without Obstructive Sleep Apnea', 'description': 'Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}, {'id': 'OG001', 'title': 'Patients With Known Obstructive Sleep Apnea', 'description': 'Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}], 'classes': [{'categories': [{'measurements': [{'value': '-38.1', 'groupId': 'OG000', 'lowerLimit': '-42.3', 'upperLimit': '-33.9'}, {'value': '-37.1', 'groupId': 'OG001', 'lowerLimit': '-43.4', 'upperLimit': '-30.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Mean respiratory rate % change from baseline measured 10 minutes following opioid administration', 'description': 'Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Respiratory Depression Following Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group; Patients Without Obstructive Sleep Apnea', 'description': 'Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}, {'id': 'OG001', 'title': 'Patients With Known Obstructive Sleep Apnea', 'description': 'Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '13.9'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '10.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration', 'description': 'Identification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Respiratory Depression Following Opioids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group; Patients Without Obstructive Sleep Apnea', 'description': 'Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}, {'id': 'OG001', 'title': 'Patients With Known Obstructive Sleep Apnea', 'description': 'Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '6.1'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration', 'description': 'Identification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group; Patients Without Obstructive Sleep Apnea', 'description': 'Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}, {'id': 'FG001', 'title': 'Patients With Known Obstructive Sleep Apnea', 'description': 'Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'unable to establish baseline for ventilation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group; Patients Without Obstructive Sleep Apnea', 'description': 'Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}, {'id': 'BG001', 'title': 'Patients With Known Obstructive Sleep Apnea', 'description': 'Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes\n\nFentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '4', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-04', 'size': 95136, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-24T09:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2019-04-27', 'resultsFirstSubmitDate': '2022-02-24', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-13', 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Depression Following Opioids', 'timeFrame': 'Mean respiratory rate % change from baseline measured 10 minutes following opioid administration', 'description': 'Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration'}, {'measure': 'Respiratory Depression Following Opioids', 'timeFrame': 'mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration', 'description': 'Identification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration'}, {'measure': 'Respiratory Depression Following Opioids', 'timeFrame': 'mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration', 'description': 'Identification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatrics', 'opioids', 'obstructive sleep apnea'], 'conditions': ['Respiratory Depression', 'Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The sole objective in this study is to evaluate if routine amounts of opioids given for tonsillectomy in children have greater amounts of respiratory depression in children with documented obstructive sleep apnea when compared with patients that do not have obstructive sleep apnea', 'detailedDescription': 'Ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and especially in opioid naïve patients. Recent evidence in adults suggests that patients with moderate to severe OSA may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have OSA. It is well known that OSA in children is significantly different from OSA in adults (e.g. gender predilection, central vs. peripheral causation). The manifestation and etiologies are very different in pediatric OSA making it a vastly different disease process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We are assessing the effect of fentanyl on children with and without OSA based on the OSA 18 questionnaire and PSG resepctively. Children must be otherwise healthy as stated above in the eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tonsillectomy or adenotonsillectomy\n* Ages 2 to 8 years\n* Polysomnography with AHI \\>6 (study group)\n* Polysomnography with AHI =0 or negative OSA 18 questionnaire (control group)\n\nExclusion Criteria:\n\n* Ages \\>8 years\n* Patients requiring pre-medication\n* Parental refusal\n* Opioid allergy/intolerance\n* Patients requiring propofol for intubation\n* Patients with known or suspected difficult airway\n* Obesity with body mass index exceeding 30- (control group only)\n* Known cardiovascular disorders\n* Known pulmonary disorders aside from asthma\n* Patients with chronic oxygen requirement\n* History of Prematurity \\<35 weeks of gestation\n* No recent URI\n* Personal of family history of malignant hyperthermia'}, 'identificationModule': {'nctId': 'NCT03938259', 'briefTitle': 'Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'H-45486'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group; patients without obstructive sleep apnea', 'description': 'Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes', 'interventionNames': ['Drug: Fentanyl']}, {'label': 'Patients with known obstructive sleep apnea', 'description': 'Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['respiratory changes, CO2, RR, TV'], 'description': 'identification of respiratory parameter changes following administration of fentanyl in children with and without OSA', 'armGroupLabels': ['Control group; patients without obstructive sleep apnea', 'Patients with known obstructive sleep apnea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas childrens Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'adam adler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No information about IP will be shared per the IRB'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology', 'investigatorFullName': 'Adam Adler MD, MS, FAAP', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}