Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
NCT ID: NCT01168492
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2010-07-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ketamine
group with triple sedation (ketamine, midazolam, meperidine)
ketamine
0.5mg/kg ketamine iv
placebo
group with conventional sedation and placebo ( midazolam, meperidine and placebo)
ketamine
0.5mg/kg ketamine iv
Interventions
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ketamine
0.5mg/kg ketamine iv
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing elective diagnostic colonoscopy
* ASA score class 1-3.
Exclusion Criteria
* Known epilepsy under treatment
* ASA score class 4 or more
* Interventional colonoscopy (e.g.polypectomy)
10 Years
19 Years
ALL
No
Sponsors
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Université de Montréal
OTHER
Responsible Party
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Denise Herzog
Associate Professor
Principal Investigators
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Denise Herzog, MD
Role: PRINCIPAL_INVESTIGATOR
Université de Montréal
Locations
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Sainte Justine Hospital
Montreal, Quebec, Canada
Countries
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References
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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.
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.
Related Links
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research center of Sainte Justine Hospital
Other Identifiers
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cme#2857
Identifier Type: -
Identifier Source: org_study_id