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NCT01298297 Clinical Trial

Efficacy of Buprenorphine for Treatment of Acute Pain

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01298297
Other study ID # TUMS-THESIS 88
Secondary ID
Status Completed
Phase Phase 4
First received February 15, 2011
Last updated December 6, 2012
Start date February 2010
Est. completion date March 2011

Study information
Verified date December 2012
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine
0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)
• Morphine
Placebo SL PLUS 5 ml Morphine sulfate (1mg/ml) IV

Locations
Country Name City State
Iran, Islamic Republic of Emergency Department, Imam Hospital Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in pain severity/score After 60 min No
Secondary Need for rescue analgesia After 60 min No
Secondary Occurrence of adverse events During 60 min Yes
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