Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
- Registration Number
- NCT01168492
- Lead Sponsor
- Université de Montréal
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Children =/> 10 years of age
- Undergoing elective diagnostic colonoscopy
- ASA score class 1-3.
- Children younger than 10 years of age
- Known epilepsy under treatment
- ASA score class 4 or more
- Interventional colonoscopy (e.g.polypectomy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ketamine ketamine group with triple sedation (ketamine, midazolam, meperidine) placebo ketamine group with conventional sedation and placebo ( midazolam, meperidine and placebo)
- Primary Outcome Measures
Name Time Method pain score after one year pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year
- Secondary Outcome Measures
Name Time Method necessity of cardiopulmonary intervention (Oxygen requirements) after one year according to Observer'sAssessment of Alertness/Sedation (OAAS) score
Trial Locations
- Locations (1)
Sainte Justine Hospital
🇨🇦Montreal, Quebec, Canada