Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT02935959
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2016-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Premedication With Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-10', 'studyFirstSubmitDate': '2016-10-12', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the degree of sedation when the child was first seen in the OR', 'timeFrame': '30 minutes after sedation', 'description': 'measure the degree of sedation using using a 5 point sedation scale. Sedation level: Agitated =1, alert= 2, calm= 3, drowsy = 4, asleep=5.'}], 'secondaryOutcomes': [{'measure': 'parental separation', 'timeFrame': '30 min after sedation', 'description': 'The parental separation anxiety scale (PSAS)'}, {'measure': 'Emergecy agitation', 'timeFrame': '30 min after induction', 'description': 'Emergence agitation will be assessed according to a 3-point scale: 1 = calm; 2 = restless but calms to verbal instructions; and 3 = combative and disoriented.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oncological Children']}, 'referencesModule': {'references': [{'pmid': '30032884', 'type': 'DERIVED', 'citation': 'Abdel-Ghaffar HS, Kamal SM, El Sherif FA, Mohamed SA. Comparison of nebulised dexmedetomidine, ketamine, or midazolam for premedication in preschool children undergoing bone marrow biopsy. Br J Anaesth. 2018 Aug;121(2):445-452. doi: 10.1016/j.bja.2018.03.039. Epub 2018 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy of nebulized dexmedetomidine, nebulized ketamine, and nebulized midazolam a premedication prior to general anesthesia (GA) in oncologic preschool children undergo bone marrow aspirate and biopsy.', 'detailedDescription': 'The preoperative period can be a traumatic time for young children undergoing surgery. Pediatric anesthesiologists strive to minimize distress for children in the operating room (OR) environment and to provide a smooth induction of anesthesia. Preoperative anxiety stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR), blood pressure, and cardiac excitability. Various drugs have been advocated as premedication to allay anxiety and facilitate the smooth separation of children from parents. The ideal premedicant in children should be readily acceptable and should have a rapid and reliable onset with minimal side effects. Dexmedetomidine is a tasteless, colorless, and odorless drug that acts as a selective α-2 adrenergic agonist with both sedative and analgesic effects via actions in the central nervous system. Ketamine is an N-methyl-d-aspartate receptor antagonist that produces a state of sedation, anesthesia, immobility, analgesia, amnesia, and dissociation from the environment. Midazolam is a water-soluble benzodiazepine known to have a rapid onset and short duration of action, as well as properties of amnesia and anxiolysis. Administered intranasally, midazolam is an effective option for conscious sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physical status I and II, scheduled for bone marrow aspirate and biopsy\n\nExclusion Criteria:\n\n* known allergy to the studied drugs,\n* organ dysfunction,\n* cardiac dysrrhythmia and/or congenital heart disease,\n* psychotropic medication use and mental retardation'}, 'identificationModule': {'nctId': 'NCT02935959', 'briefTitle': 'Premedication With Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Premedication With Different Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children', 'orgStudyIdInfo': {'id': '349'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nebulized ketamine', 'description': 'patients will be premedicated with nebulized ketamine solution (2 mg/kg)', 'interventionNames': ['Drug: nebulized ketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nebulized dexmedetomidine', 'description': 'patients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg)', 'interventionNames': ['Drug: nebulized Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nebulized midazolam', 'description': 'patients will be premedicated with midazolam (0.2 mg/kg) nebulized solution', 'interventionNames': ['Drug: nebulized midazolam']}], 'interventions': [{'name': 'nebulized ketamine', 'type': 'DRUG', 'description': 'Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of 100% oxygen at 6 L/min for 10 to 15 minutes (30 minutes before GA). Treatment will be stopped when the nebulizer began to sputter.', 'armGroupLabels': ['nebulized ketamine']}, {'name': 'nebulized Dexmedetomidine', 'type': 'DRUG', 'armGroupLabels': ['nebulized dexmedetomidine']}, {'name': 'nebulized midazolam', 'type': 'DRUG', 'armGroupLabels': ['nebulized midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171516', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'fatma a elsherif, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'South Egypt Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia,ICU and pain management', 'investigatorFullName': 'Shereen Mamdouh', 'investigatorAffiliation': 'Assiut University'}}}}