NCT01168492

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Université de Montréal · Academic / Other
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	ketamine	0.5mg/kg ketamine iv

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2010-07-23
• Last updated: 2014-12-04

Locations

1 site across 1 country: Canada