NCT01553435

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

March 6, 2012

Last Update Submit

April 12, 2015

Conditions

PainOpioid ToleranceAnalgesia Tolerance

Keywords

DextromethorphanMorphineFentanylOpioidanalgesiaEfficacy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    two years

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

    Two years

Study Arms (2)

Dextromethorphan, opioid analgisia, efficacy

PLACEBO COMPARATOR
Drug: Dextromethorphan

Placebo,opioid analgesia, efficacy

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DextromethorphanDRUG

The study medicines shall be administered via tube.

Dextromethorphan, opioid analgisia, efficacy
PlaceboDRUG

The study medicines shall be administered via tube.

Placebo,opioid analgesia, efficacy

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients above 2 years, admitted in PICU
  • On Morphine or Fentanyl infusions for more than 48 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdul Aziz Medical City

Riyadh, Central, 11426, Saudi Arabia

Location

Related Publications (1)

  • 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.

    PMID: 27867308DERIVED

MeSH Terms

Conditions

PainAgnosia

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Pediatric Intensivist

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 14, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2015

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

SA(1)