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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Mohammed Naeem, King Abdullah International Medical Research Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01553435
First Posted: March 14, 2012
Last Update Posted: April 14, 2015
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):
Mohammed Naeem, King Abdullah International Medical Research Center
  Purpose
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients

Condition Intervention
Pain Opioid Tolerance Analgesia Tolerance Drug: Dextromethorphan Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients

Resource links provided by NLM:


Further study details as provided by Mohammed Naeem, King Abdullah International Medical Research Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • 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


Estimated Enrollment: 36
Study Start Date: January 2011
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01553435


Locations
Saudi Arabia
King Abdul Aziz Medical City
Riyadh, Central, Saudi Arabia, 11426
Sponsors and Collaborators
King Abdullah International Medical Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mohammed Naeem, Consultant Pediatric Intensivist, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT01553435     History of Changes
Other Study ID Numbers: RC 09-120
First Submitted: March 6, 2012
First Posted: March 14, 2012
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by Mohammed Naeem, King Abdullah International Medical Research Center:
Dextromethorphan
Morphine
Fentanyl
Opioid
analgesia
Efficacy

Additional relevant MeSH terms:
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dextromethorphan
N-Methylaspartate
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Agonists