Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 10:34 PM
Study NCT ID:
NCT04678050
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2020-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The pedo-dentist, the independent observer/data collector, and participants will be blind to the type of intervention. The study drugs will be prepared by an anesthesiologist who will not participate in the observation of the data. All the lines and syringes will be wrapped to mask colors of the sedative drugs, and the syringes will be label coded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The study participants will be allocated into two equal groups. Subjects in group I will receive ketofol solution (ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h. Subjects in group II will receive the Dex solution (4 µg/mL). A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h. Non-invasive blood pressure (mean ABP) peripheral oxygen saturation, heart rate, and respiratory rate will be assessed at baseline, at 2 minutes, then at 5 minutes intervals till 60 minutes. Ramsay sedation and Aldrete's recovery rating scores were assessed before, during, and after the procedure."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Number of interruptions', 'timeFrame': 'through study completion, an average of 3 month', 'description': 'the Number of interruptions that occurred during the procedure'}], 'secondaryOutcomes': [{'measure': 'total dose of rescue drug', 'timeFrame': 'through study completion, an average of 3 month', 'description': 'total dose of rescue propofol in mg'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vital Signs']}, 'descriptionModule': {'briefSummary': 'Dental fear and anxiety remain common problems that should be managed by both the dentist and the anesthetist. The currently available evidence for safe and effective sedative drugs for children undergoing the dental procedure is scarce The aim of this study was to compare the safety and efficacy of intravenous ketofol versus dexmedetomidine (Dex) as premedications a sedative in anxious children undergoing dental pulp therapy', 'detailedDescription': "This double-blind, parallel-group, randomized clinical study will recruiter anxious children who will undergo dental pulp therapy. The study participants will be allocated into two equal groups. Subjects in group I will receive ketofol solution (ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h. Subjects in group II will receive the Dex solution (4 µg/mL). A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h. Non-invasive blood pressure (mean ABP), peripheral oxygen saturation, heart rate, and respiratory rate will be assessed at baseline, at 2 minutes, then at 5 minutes intervals till 60 minutes. Ramsay sedation and Aldrete's recovery rating scores will be assessed before, during, and after the procedure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA-I children,\n* aged 5-10 years-old,\n* requiring dental pulp therapy\n\nExclusion Criteria:\n\n* ASA class ≥ II;\n* previous experience with GA or Conscious sedation (CS);\n* dental treatment expected to exceed 45 minutes;\n* history of allergy to local anesthetics, Dex, propofol, ketamine, eggs, or soya;\n* respiratory tract infections'}, 'identificationModule': {'nctId': 'NCT04678050', 'briefTitle': 'Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics Undergoing Dental Procedures: a Comparative Study', 'orgStudyIdInfo': {'id': 'IRB 000-6379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group I received ketamine/propofol (ketofol) solution', 'description': 'ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h.', 'interventionNames': ['Drug: Ketamine/ propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group II received the Dex solution (4 µg/mL', 'description': 'A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Ketamine/ propofol', 'type': 'DRUG', 'otherNames': ['Ketofol'], 'description': 'ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h.', 'armGroupLabels': ['group I received ketamine/propofol (ketofol) solution']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'Dex solution (4 µg/mL). A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h', 'armGroupLabels': ['group II received the Dex solution (4 µg/mL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Abassia', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Alaa Ismail, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of research ethics committee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anaesthesia and intensive care', 'investigatorFullName': 'Rania Maher Hussien, MD', 'investigatorAffiliation': 'Ain Shams University'}}}}