Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT00387556
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2006-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ondansetron Reduce Vomiting Associated With Ketamine PSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-09', 'studyFirstSubmitDate': '2006-10-12', 'studyFirstSubmitQcDate': '2006-10-12', 'lastUpdatePostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of vomiting', 'timeFrame': 'Duration of ED stay and after discharge', 'description': 'The primary outcomes in this study were vomiting in the ED and after discharge, as determined by telephone follow-up'}], 'secondaryOutcomes': [{'measure': 'Length of ED stay', 'timeFrame': 'Duration of ED stay', 'description': 'Secondary outcome measures were length of ED stay'}, {'measure': 'Satisfaction with Sedation', 'timeFrame': 'Length of ED stay.', 'description': 'patient or parent satisfaction with their sedation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ketamine', 'children', 'emesis'], 'conditions': ['Conscious Sedation']}, 'descriptionModule': {'briefSummary': 'Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting associated with ketamine during procedural sedation in the pediatric emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 1-21 years, ASA I or II, fracture of dislocation reduction\n\nExclusion Criteria:\n\n* age \\< 1 year, ASA III or IV, hypertension, glaucoma, acute globe injury, increased intracranial pressure or central nervous system mass lesion, major psychiatric disorder, porphyria, previous adverse reaction to ketamine or ondansetron, parent, guardian or patient unwilling to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT00387556', 'briefTitle': 'Ondansetron Reduce Vomiting Associated With Ketamine PSA', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Does Ondansetron Reduce the Incidence of Vomiting When Used in Conjunction With Ketamine During Procedural Sedation in the Pediatric Emergency Department', 'orgStudyIdInfo': {'id': '02-0528'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine + Ondansetron', 'description': 'ketamine 1 mg/kg IV (maximum single dose 100 mg)+ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)', 'interventionNames': ['Drug: Ondansetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ketamine + Placebo', 'description': 'ketamine 1 mg/kg IV (maximum single dose 100 mg)+2 ml normal saline solution IV (placebo', 'interventionNames': ['Drug: Ondansetron']}], 'interventions': [{'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)', 'armGroupLabels': ['Ketamine + Ondansetron', 'Ketamine + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Childrens Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Joe E Wathen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado Health Science Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}