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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01298297

Enrollment

Registered

2011-02-17

Start date

2010-02-28

Completion date

2011-03-31

Last updated

2012-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

Buprenorphine, acute pain, analgesia

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

Interventions

DRUGBuprenorphine

0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)

DRUGMorphine

Placebo SL PLUS 5 ml Morphine sulfate (1mg/ml) IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Change in pain severity/score	After 60 min

Secondary

Measure	Time frame
Need for rescue analgesia	After 60 min
Occurrence of adverse events	During 60 min

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026