NCT00323154

Brief Summary

Itching is a frequent and disturbing side effect of the use of pain medication such as morphine. In the post-operative period, it can be more distressing to pediatric patients than their pain. The current first line treatment, an antihistamine (Benadryl), has a low efficacy. This treatment causes sleepiness and may be dangerous when used in combination with other drugs. Nalbuphine has analgesic properties similar to morphine as well as the ability to reverse some morphine-induced side effects, such as respiratory depression and itching. Nalbuphine has been used effectively for patients undergoing Caesarean sections. However, the effectiveness of nalbuphine in the pediatric population has not been investigated. We want to determine the efficacy of nalbuphine in the treatment of itching after morphine for postoperative pain relief. We will use a novel method to measure the effect of the treatment using an intensity scale before and after the drug, to determine the intensity difference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

9 months

First QC Date

May 8, 2006

Last Update Submit

September 24, 2008

Conditions

Pruritis

Keywords

Morphine, analgesia

Outcome Measures

Primary Outcomes (1)

  • Pruritis intensity

Secondary Outcomes (1)

  • Pain, sedation

Interventions

NalbuphineDRUG

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Postoperative morphine administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia's Children's Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

PruritusAgnosia

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Carolyne Montgomery, MD

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2006

First Posted

May 9, 2006

Study Start

March 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

CA(1)