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
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Abdul Aziz Medical City | Riyadh | Central |
Lead Sponsor | Collaborator |
---|---|
King Abdullah International Medical Research Center |
Saudi Arabia,
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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