Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-27 @ 10:28 AM
Study NCT ID:
NCT01168492
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2010-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2010-07-21', 'studyFirstSubmitQcDate': '2010-07-22', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'after one year', 'description': 'pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year'}], 'secondaryOutcomes': [{'measure': 'necessity of cardiopulmonary intervention (Oxygen requirements)', 'timeFrame': 'after one year', 'description': "according to Observer'sAssessment of Alertness/Sedation (OAAS) score"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pediatric', 'gastroscopy', 'colonoscopy', 'sedation', 'ketamine'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '15114309', 'type': 'BACKGROUND', 'citation': 'Gilger MA, Spearman RS, Dietrich CL, Spearman G, Wilsey MJ Jr, Zayat MN. Safety and effectiveness of ketamine as a sedative agent for pediatric GI endoscopy. Gastrointest Endosc. 2004 May;59(6):659-63. doi: 10.1016/s0016-5107(04)00180-4.'}, {'pmid': '18440381', 'type': 'BACKGROUND', 'citation': 'McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc. 2008 May;67(6):910-23. doi: 10.1016/j.gie.2007.12.046.'}], 'seeAlsoLinks': [{'url': 'http://www.chu-sainte-justine.org/recherche/', 'label': 'research center of Sainte Justine Hospital'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ketamine, midazolam, and meperidine are more effective than midazolam and meperidine alone for procedural sedation and analgesia in pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side effects and the necessity of rescue doses.', 'detailedDescription': '90 patients will be included. The sedation will include 0.1mg/kg, max 5mg iv of midazolam, 1mg/kg, max 50mg iv of meperidine, and placebo (0.9%NaCl) or ketamine 0.5mg/kg iv. Rescue doses will be given as usual, using meperidine and or midazolam 50% of the initial dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children =/\\> 10 years of age\n* Undergoing elective diagnostic colonoscopy\n* ASA score class 1-3.\n\nExclusion Criteria:\n\n* Children younger than 10 years of age\n* Known epilepsy under treatment\n* ASA score class 4 or more\n* Interventional colonoscopy (e.g.polypectomy)'}, 'identificationModule': {'nctId': 'NCT01168492', 'briefTitle': 'Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': 'Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation', 'orgStudyIdInfo': {'id': 'cme#2857'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ketamine', 'description': 'group with triple sedation (ketamine, midazolam, meperidine)', 'interventionNames': ['Drug: ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'group with conventional sedation and placebo ( midazolam, meperidine and placebo)', 'interventionNames': ['Drug: ketamine']}], 'interventions': [{'name': 'ketamine', 'type': 'DRUG', 'otherNames': ['no other names'], 'description': '0.5mg/kg ketamine iv', 'armGroupLabels': ['ketamine', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sainte Justine Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Denise Herzog, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Denise Herzog', 'investigatorAffiliation': 'Université de Montréal'}}}}