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Efficacy of Buprenorphine for Treatment of Acute Pain

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ClinicalTrials.gov Identifier: NCT01298297
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Buprenorphine Drug: Morphine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Sublingual Buprenorphine With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Long Bone Fracture
Study Start Date : February 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Change in pain severity/score [ Time Frame: After 60 min ]

Secondary Outcome Measures :
  1. Need for rescue analgesia [ Time Frame: After 60 min ]
  2. Occurrence of adverse events [ Time Frame: During 60 min ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298297

Iran, Islamic Republic of
Emergency Department, Imam Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
More Information

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01298297     History of Changes
Other Study ID Numbers: TUMS-THESIS 88
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by Tehran University of Medical Sciences:
Buprenorphine, acute pain, analgesia

Additional relevant MeSH terms:
Acute Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists