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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168492
• Other study ID #: cme#2857
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2010
• Last updated: December 3, 2014
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: December 2014
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 19 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• ketamine
0.5mg/kg ketamine iv

Locations

Country	Name	City	State
Canada	Sainte Justine Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year	after one year	No
Secondary	necessity of cardiopulmonary intervention (Oxygen requirements)	according to Observer'sAssessment of Alertness/Sedation (OAAS) score	after one year	Yes

External Links

•   research center of Sainte Justine Hospital