Efficacy of Buprenorphine for Treatment of Acute Pain

Tehran University of Medical Sciences80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Acute Pain

Interventions

BuprenorphineDRUG

0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)

MorphineDRUG

Placebo SL PLUS 5 ml Morphine sulfate (1mg/ml) IV

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (1)

Emergency Department, Imam Hospital

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Change in pain severity/score

Time frame: After 60 min

Secondary Outcomes

Need for rescue analgesia

Time frame: After 60 min

Occurrence of adverse events

Time frame: During 60 min

Data from ClinicalTrials.gov

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