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

This study has been completed.
Information provided by (Responsible Party):
Denise Herzog, Université de Montréal Identifier:
First received: July 21, 2010
Last updated: December 3, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Drug: ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation

Resource links provided by NLM:

Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • necessity of cardiopulmonary intervention (Oxygen requirements) [ Time Frame: after one year ]
    according to Observer'sAssessment of Alertness/Sedation (OAAS) score

Enrollment: 90
Study Start Date: July 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ketamine
group with triple sedation (ketamine, midazolam, meperidine)
Drug: ketamine
0.5mg/kg ketamine iv
Other Name: no other names
Placebo Comparator: placebo
group with conventional sedation and placebo ( midazolam, meperidine and placebo)
Drug: ketamine
0.5mg/kg ketamine iv
Other Name: no other names

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.

Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01168492

Canada, Quebec
Sainte Justine Hospital
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
Université de Montréal
Principal Investigator: Denise Herzog, MD Université de Montréal
  More Information

Additional Information:
Responsible Party: Denise Herzog, Associate Professor, Université de Montréal Identifier: NCT01168492     History of Changes
Other Study ID Numbers: cme#2857
Study First Received: July 21, 2010
Last Updated: December 3, 2014

Keywords provided by Université de Montréal:

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017