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Efficacy of Buprenorphine for Treatment of Acute Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01298297
First received: February 15, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Acute Pain
 Drug: Buprenorphine
Drug: Morphine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Change in pain severity/score [ Time Frame: After 60 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need for rescue analgesia [ Time Frame: After 60 min ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: During 60 min ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: February 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298297

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

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01298297     History of Changes
Other Study ID Numbers: TUMS-THESIS 88
Study First Received: February 15, 2011
Last Updated: December 6, 2012
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Buprenorphine
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013