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 because the information has not been verified recently.
Verified March 2012 by King Abdullah International Medical Research Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mohammed Naeem, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier:
NCT01553435
First received: March 6, 2012
Last updated: March 13, 2012
Last verified: March 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Length of Hospital Stay in two groups


Estimated Enrollment: 36
Study Start Date: January 2011
Estimated Primary Completion Date: January 2014 (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

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
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
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: NCT01553435

Locations
Saudi Arabia
King Abdul Aziz Medical City Recruiting
Riyadh, Central, Saudi Arabia, 11426
Contact: Mohammed Naeem Naeem       naeem.mdpicu@yahoo.com   
Principal Investigator: Mohammed Naeem, MD         
Principal Investigator: Mohammed Naeem         
Sponsors and Collaborators
King Abdullah International Medical Research Center
  More Information

No publications provided

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
Study First Received: March 6, 2012
Last Updated: March 13, 2012
Health Authority: Saudi Arabia: Saudi Food and Drug Authority (Registered Study)

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

Additional relevant MeSH terms:
N-Methylaspartate
Dextromethorphan
Analgesics, Opioid
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 24, 2014