Efficacy of Buprenorphine for Treatment of Acute Pain

December 6, 2012 updated by: Tehran University of Medical Sciences

Comparison of Sublingual Buprenorphine With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Long Bone Fracture

The purpose of this study is to determine whether sublingual buprenorphine is effective in the treatment of acute pain in adult patients with extremity bone fractures

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical diagnosis of extremity bone fracture Age>16 years Acute pain of score 3 or greater on numerical rating scale

Exclusion Criteria:

Long term use of opium or opioids/dependence Previous administration of analgesic Known sensitivity to opioids Pregnant women History of medical problems (liver, kidney, heart, hematologic)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Buprenorphine + Placebo
Drug: Buprenorphine
0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)
Placebo Comparator: Morphine + Placebo
Drug: Morphine
Placebo SL PLUS 5 ml Morphine sulfate (1mg/ml) IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pain severity/score
Time Frame: After 60 min
After 60 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for rescue analgesia
Time Frame: After 60 min
After 60 min
Occurrence of adverse events
Time Frame: During 60 min
During 60 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUMS-THESIS 88

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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