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

King Abdullah International Medical Research Center

Status: Unknown

Conditions: Opioid Tolerance; Pain; Analgesia Tolerance

Treatments: Drug: Dextromethorphan; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01553435

RC 09-120

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Dextromethorphan, opioid analgisia, efficacy

Placebo Comparator group

Treatment:

Drug: Dextromethorphan

Placebo,opioid analgesia, efficacy

Placebo Comparator group

Treatment:

Drug: Placebo