Back to resultsEfficacy of Buprenorphine for Treatment of Acute Pain
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Buprenorphine
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Buprenorphine, acute pain, analgesia
Eligibility 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)
Sites / Locations
- Emergency Department, Imam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Buprenorphine + Placebo
Morphine + Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in pain severity/score
Secondary Outcome Measures
Need for rescue analgesia
Occurrence of adverse events
Full Information
NCT ID
NCT01298297
First Posted
February 15, 2011
Last Updated
December 6, 2012
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01298297
Brief Title
Efficacy of Buprenorphine for Treatment of Acute Pain
Official Title
Comparison of Sublingual Buprenorphine With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Long Bone Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Buprenorphine, acute pain, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buprenorphine + Placebo
Arm Type
Active Comparator
Arm Title
Morphine + Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Placebo SL PLUS 5 ml Morphine sulfate (1mg/ml) IV
Primary Outcome Measure Information:
Title
Change in pain severity/score
Time Frame
After 60 min
Secondary Outcome Measure Information:
Title
Need for rescue analgesia
Time Frame
After 60 min
Title
Occurrence of adverse events
Time Frame
During 60 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Emergency Department, Imam Hospital
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Buprenorphine for Treatment of Acute Pain
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