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Completed

NCT Number: NCT01298297

Efficacy of Buprenorphine for Treatment of Acute Pain

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

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Key information

Conditions

Acute Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emergency Department, Imam Hospital

Tehran, Tehran Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

buprenorphine

Drug

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

Morphine

Drug

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

Primary outcomes

  1. Change in pain severity/score

    Time frame: After 60 min

Secondary outcomes

  1. Need for rescue analgesia

    Time frame: After 60 min

  2. Occurrence of adverse events

    Time frame: During 60 min

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2011
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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