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

December 3, 2014 updated by: Denise Herzog, Université de Montréal
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T1C5
        • Sainte Justine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ketamine
group with triple sedation (ketamine, midazolam, meperidine)
Drug: ketamine
0.5mg/kg ketamine iv
Other Names:
  • no other names
PLACEBO_COMPARATOR: placebo
group with conventional sedation and placebo ( midazolam, meperidine and placebo)
Drug: ketamine
0.5mg/kg ketamine iv
Other Names:
  • no other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
necessity of cardiopulmonary intervention (Oxygen requirements)
Time Frame: after one year
according to Observer'sAssessment of Alertness/Sedation (OAAS) score
after one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (ESTIMATE)

July 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cme#2857

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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