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

February 15, 2011
December 6, 2012
February 2010
March 2011   (final data collection date for primary outcome measure)
Change in pain severity/score [ Time Frame: After 60 min ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01298297 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of Buprenorphine for Treatment of Acute Pain
Comparison of Sublingual Buprenorphine With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Long Bone Fracture

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Pain
  • Drug: Buprenorphine
    0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)
  • Drug: Morphine
    Placebo SL PLUS 5 ml Morphine sulfate (1mg/ml) IV
  • Active Comparator: Buprenorphine + Placebo
    Intervention: Drug: Buprenorphine
  • Placebo Comparator: Morphine + Placebo
    Intervention: Drug: Morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2011
March 2011   (final data collection date for primary outcome measure)

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)

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01298297
TUMS-THESIS 88
No
Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Not Provided
Tehran University of Medical Sciences
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP