Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Jul 2010
Longer than P75 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedDecember 4, 2014
December 1, 2014
3 years
July 21, 2010
December 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain score
pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year
after one year
Secondary Outcomes (1)
necessity of cardiopulmonary intervention (Oxygen requirements)
after one year
Study Arms (2)
ketamine
EXPERIMENTALgroup with triple sedation (ketamine, midazolam, meperidine)
placebo
PLACEBO COMPARATORgroup with conventional sedation and placebo ( midazolam, meperidine and placebo)
Interventions
Eligibility Criteria
You may qualify if:
- Children =/\> 10 years of age
- Undergoing elective diagnostic colonoscopy
- ASA score class 1-3.
You may not qualify if:
- Children younger than 10 years of age
- Known epilepsy under treatment
- ASA score class 4 or more
- Interventional colonoscopy (e.g.polypectomy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sainte Justine Hospital
Montreal, Quebec, H3T1C5, Canada
Related Publications (2)
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: 15114309BACKGROUNDMcQuaid 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.
PMID: 18440381BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Herzog, MD
Université de Montréal
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 21, 2010
First Posted
July 23, 2010
Study Start
July 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
December 4, 2014
Record last verified: 2014-12