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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Université de Montréal.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT01168492
First received: July 21, 2010
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

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
Pain
Conscious Sedation
 Drug: ketamine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • pain score [ Time Frame: after one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    according to Observer'sAssessment of Alertness/Sedation (OAAS) score


Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (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.

  Eligibility

Ages Eligible for Study:   10 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168492

Contacts
Contact: Denise Herzog, MD 514 345-4931 ext 4626 deniseherzog@hotmail.com
Contact: Christophe Faure, MD 514 345-4931 ext 4626 christophe.faure@umontreal.ca

Locations
Canada, Quebec
Sainte Justine Hospital Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Herzog Denise, MD     514 345-4931 ext 4626     deniseherzog@hotmail.com    
Contact: Christophe Faure, MD     514 345-4931 ext 4626     christophe.faure@umontreal.ca    
Principal Investigator: Denise Herzog, MD            
Sub-Investigator: Christophe Faure, MD            
Sponsors and Collaborators
Université de Montréal
Investigators
Principal Investigator: Denise Herzog, MD Université de Montréal
  More Information

Additional Information:
research center of Sainte Justine Hospital  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Denise Herzog, University of Montreal
ClinicalTrials.gov Identifier: NCT01168492     History of Changes
Other Study ID Numbers: cme#2857
Study First Received: July 21, 2010
Last Updated: July 22, 2010
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by Université de Montréal:
pediatric
gastroscopy
colonoscopy
sedation
ketamine

Additional relevant MeSH terms:
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013