Efficacy of Buprenorphine for Treatment of Acute Pain

Phase 4

Completed

• Conditions: Acute Pain
• Interventions: Drug: Buprenorphine; Drug: Morphine

• Registration Number: NCT01298297
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-17
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine + Placebo	Buprenorphine	-
Morphine + Placebo	Morphine	-

Primary Outcome Measures

Name	Time	Method
Change in pain severity/score	After 60 min

Secondary Outcome Measures

Name	Time	Method
Need for rescue analgesia	After 60 min
Occurrence of adverse events	During 60 min

Trial Locations

Locations (1)

Emergency Department, Imam Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of