Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients

April 12, 2015 updated by: Mohammed Naeem, King Abdullah International Medical Research Center
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

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

  • Saudi Arabia
    • Central
      • Riyadh, Central, Saudi Arabia, 11426
        • King Abdul Aziz Medical City

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

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Patients above 2 years, admitted in PICU
  • On Morphine or Fentanyl infusions for more than 48 hours

Exclusion Criteria:

  • Patients under 2 years of age
  • Patients with anticipated PICU length of stay less than 3 days.
  • Patients shall be excluded if Morphine or Fentanyl infusions not continued for the minimum duration of 72 hours after enrollment
  • Patients develops hemodynamic instability
  • Patients with Hepatic failure
  • Withdrawal request by parent(s)/guardian/family

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Dextromethorphan, opioid analgisia, efficacy
Drug: Dextromethorphan
The study medicines shall be administered via tube.
Placebo Comparator: Placebo,opioid analgesia, efficacy
Drug: Placebo
The study medicines shall be administered via tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
Time Frame: Two years
Control of pain
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
Time Frame: two years
Duration of ventilation in both groups
two years
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
Time Frame: Two years
Length of Hospital Stay in two groups
Two years

Collaborators and Investigators

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

Sponsor

King Abdullah International Medical Research Center

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

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

January 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 12, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 09-120

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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