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

• ClinicalTrials.gov Identifier: NCT01168492
• Recruitment Status: Completed
• First Posted: July 23, 2010
• Last Update Posted: December 4, 2014
• Sponsor: Université de Montréal
• Information provided by (Responsible Party): Denise Herzog, Université de Montréal

Tracking Information

• First Submitted Date: July 21, 2010
• First Posted Date: July 23, 2010
• Last Update Posted Date: December 4, 2014
• Study Start Date: July 2010
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 22, 2010)

pain score [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 22, 2010)

necessity of cardiopulmonary intervention (Oxygen requirements) [ Time Frame: after one year ]

according to Observer'sAssessment of Alertness/Sedation (OAAS) score

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
• Official Title: Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain

Intervention

Drug: ketamine

0.5mg/kg ketamine iv

Other Name: no other names

Study Arms

• Experimental: ketamine
  group with triple sedation (ketamine, midazolam, meperidine)
  Intervention: Drug: ketamine
• Placebo Comparator: placebo
  group with conventional sedation and placebo ( midazolam, meperidine and placebo)
  Intervention: Drug: ketamine

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 22, 2010): 90
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01168492
• Other Study ID Numbers: cme#2857
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Denise Herzog, Université de Montréal
• Study Sponsor: Université de Montréal
• Collaborators: Not Provided

Investigators

• Principal Investigator: Denise Herzog, MD; Université de Montréal

• PRS Account: Université de Montréal
• Verification Date: December 2014