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NCT01553435 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01553435
Other study ID # RC 09-120
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 6, 2012
Last updated April 12, 2015
Start date January 2011

Study information
Verified date April 2015
Source King Abdullah International Medical Research Center
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: Saudi Food and Drug Authority (Registered Study)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 36
Est. completion date
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 14 Years
Eligibility 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 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

Related Conditions & MeSH terms

Intervention

Drug:
• Dextromethorphan
The study medicines shall be administered via tube.
• Placebo
The study medicines shall be administered via tube.

Locations
Country Name City State
Saudi Arabia King Abdul Aziz Medical City Riyadh Central

Sponsors (1)
Lead Sponsor Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients Control of pain Two years No
Secondary Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients Duration of ventilation in both groups two years No
Secondary Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients Length of Hospital Stay in two groups Two years No
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