Overview

This trial is active, not recruiting.

Conditions pain, opioid tolerance, analgesia tolerance
Treatments dextromethorphan, placebo
Sponsor King Abdullah International Medical Research Center
Start date January 2011
End date January 2015
Trial size 36 participants
Trial identifier NCT01553435, RC 09-120

Summary

Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients

United States No locations recruiting
Other Countries No locations recruiting

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
Arm
(Placebo Comparator)
dextromethorphan
The study medicines shall be administered via tube.
(Placebo Comparator)
placebo
The study medicines shall be administered via tube.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants from 2 years up to 14 years old.

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

Additional Information

Official title Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by King Abdullah International Medical Research Center.