Status:
COMPLETED
Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
Lead Sponsor:
Université de Montréal
Conditions:
Pain
Eligibility:
All Genders
10-19 years
Phase:
PHASE4
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 digestiv...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Children =/\> 10 years of age
- Undergoing elective diagnostic colonoscopy
- ASA score class 1-3.
Exclusion
- Children younger than 10 years of age
- Known epilepsy under treatment
- ASA score class 4 or more
- Interventional colonoscopy (e.g.polypectomy)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01168492
Start Date
July 1 2010
End Date
July 1 2013
Last Update
December 4 2014
Active Locations (1)
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1
Sainte Justine Hospital
Montreal, Quebec, Canada, H3T1C5