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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168492
First Posted: July 23, 2010
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Denise Herzog, Université de Montréal
  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 Drug: ketamine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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 Denise Herzog, 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168492


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

Additional Information:
Publications:
Responsible Party: Denise Herzog, Associate Professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01168492     History of Changes
Other Study ID Numbers: cme#2857
First Submitted: July 21, 2010
First Posted: July 23, 2010
Last Update Posted: December 4, 2014
Last Verified: December 2014

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

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