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

• Sponsor: King Abdullah International Medical Research Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01553435
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain; Opioid Tolerance; Analgesia Tolerance	Drug: Dextromethorphan; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

   Control of pain

Secondary Outcome Measures

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

   Duration of ventilation in both groups

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

   Length of Hospital Stay in two groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	King Abdul Aziz Medical City	Riyadh	Central	Saudi Arabia	11426

Sponsors and Collaborators

• King Abdullah International Medical Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Naeem, Consultant Pediatric Intensivist, King Abdullah International Medical Research Center
• ClinicalTrials.gov Identifier: NCT01553435
• Other Study ID Numbers: RC 09-120
• First Posted: Mar 14, 2012
• Last Update Posted: Apr 14, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Mohammed Naeem, Consultant Pediatric Intensivist, King Abdullah International Medical Research Center: Dextromethorphan; Morphine; Fentanyl; Opioid; analgesia; Efficacy
• Additional relevant MeSH terms: Agnosia; Dextromethorphan

Study Results

No Results Posted as of Apr 14, 2015