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

NCT ID: NCT01553435

Last Updated: 2015-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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

Detailed Description

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Conditions

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Pain Opioid Tolerance Analgesia Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dextromethorphan, opioid analgisia, efficacy

Group Type PLACEBO_COMPARATOR

Dextromethorphan

Intervention Type DRUG

The study medicines shall be administered via tube.

Placebo,opioid analgesia, efficacy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The study medicines shall be administered via tube.

Interventions

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Dextromethorphan

The study medicines shall be administered via tube.

Intervention Type DRUG

Placebo

The study medicines shall be administered via tube.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Naeem

Consultant Pediatric Intensivist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Abdul Aziz Medical City

Riyadh, Central, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 27867308 (View on PubMed)

Other Identifiers

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RC 09-120

Identifier Type: -

Identifier Source: org_study_id

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