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Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation

Information source: Université de Montréal
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: ketamine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Université de Montréal

Official(s) and/or principal investigator(s):
Denise Herzog, MD, Principal Investigator, Affiliation: Université de Montréal

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.

Clinical Details

Official title: Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: pain score

Secondary outcome: necessity of cardiopulmonary intervention (Oxygen requirements)

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 as usual, using meperidine and or midazolam 50% of the initial dose.

Eligibility

Minimum age: 10 Years. Maximum age: 19 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children =/> 10 years of age

- Undergoing elective diagnostic colonoscopy

- ASA score class 1-3.

Exclusion Criteria:

- Children younger than 10 years of age

- Known epilepsy under treatment

- ASA score class 4 or more

- Interventional colonoscopy (e. g.polypectomy)

Locations and Contacts

Sainte Justine Hospital, Montreal, Quebec H3T1C5, Canada
Additional Information

research center of Sainte Justine Hospital

Related publications:

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.

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. Review.

Starting date: July 2010
Last updated: December 3, 2014

Page last updated: August 23, 2015

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