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Buprenorphine in Acute Renal Colic Pain Management

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01546701
Enrollment
80
Registered
2012-03-07
Start date
2011-03-31
Completion date
2012-04-30
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 Management, Renal Colic

Brief summary

The purpose of this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department.

Interventions

DRUGBuprenorphine

2 mg sublingual tablet

DRUGMorphine

0.1 mg/kg IV morphine

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* clinical diagnosis of acute renal colic; positive urinalysis of hematuria; pain score more than 3 in Numerical Rating Score (NRS); patients sign the informed consent to enroll.

Exclusion criteria

* previous history of seizures; cardiovascular, hepatic, renal or metabolic diseases; * febrile patients (T \> 38°C); * hemodynamically unstable patients ( Systolic Blood Pressure \< 90 mmHg); * pregnant patients; * patients with abdominal tenderness as a sign of peritoneal inflammation; * any clinical suspicion for diseases other than urolithiasis like abdominal aortic aneurysm or dissection; * patients with a history of drug addiction or known allergy to opioids; * patients who had used analgesics 6 hours before arriving.

Design outcomes

Primary

MeasureTime frameDescription
change in pain score20 and 40 minuteschange in pain severity based on Numerical Rating Score

Secondary

MeasureTime frameDescription
treatment side effects40 minutesexperiencing any side effects by the patients as a result of treatment protocols.

Countries

Iran

Outcome results

None listed

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