Back to resultsEffect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients
Primary Purpose
Pain, Opioid Tolerance, Analgesia Tolerance
Status
Unknown status
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Dextromethorphan
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Dextromethorphan, Morphine, Fentanyl, Opioid, analgesia, Efficacy
Eligibility 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
Sites / Locations
- King Abdul Aziz Medical City
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Placebo Comparator
Arm Label
Dextromethorphan, opioid analgisia, efficacy
Placebo,opioid analgesia, efficacy
Arm Description
Outcomes
Primary Outcome Measures
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
Control of pain
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT01553435
First Posted
March 6, 2012
Last Updated
April 12, 2015
Sponsor
King Abdullah International Medical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01553435
Brief Title
Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients
Official Title
Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdullah International Medical Research Center
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Opioid Tolerance, Analgesia Tolerance
Keywords
Dextromethorphan, Morphine, Fentanyl, Opioid, analgesia, Efficacy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dextromethorphan, opioid analgisia, efficacy
Arm Type
Placebo Comparator
Arm Title
Placebo,opioid analgesia, efficacy
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
The study medicines shall be administered via tube.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The study medicines shall be administered via tube.
Primary Outcome Measure Information:
Title
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
Description
Control of pain
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
Description
Duration of ventilation in both groups
Time Frame
two years
Title
Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients
Description
Length of Hospital Stay in two groups
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
King Abdul Aziz Medical City
City
Riyadh
State/Province
Central
ZIP/Postal Code
11426
Country
Saudi Arabia
12. IPD Sharing Statement
Citations:
PubMed Identifier
27867308
Citation
Naeem M, Al Alem H, Al Shehri A, Al-Jeraisy M. Effect of N-Methyl-D-Aspartate Receptor Antagonist Dextromethorphan on Opioid Analgesia in Pediatric Intensive Care Unit. Pain Res Manag. 2016;2016:1658172. doi: 10.1155/2016/1658172. Epub 2016 Oct 27.
Results Reference
derived
Learn more about this trial
Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients
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