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Efficacy of Buprenorphine for Treatment of Acute Pain

NCT ID: NCT01298297

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-03-31

Brief Summary

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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

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Conditions

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Acute Pain

Keywords

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Buprenorphine, acute pain, analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Buprenorphine + Placebo

Group Type ACTIVE_COMPARATOR

Buprenorphine

Intervention Type DRUG

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

Morphine + Placebo

Group Type PLACEBO_COMPARATOR

Morphine

Intervention Type DRUG

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

Interventions

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Buprenorphine

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

Intervention Type DRUG

Morphine

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Emergency Department, Imam Hospital

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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TUMS-THESIS 88

Identifier Type: -

Identifier Source: org_study_id