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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014