Buprenorphine in Acute Renal Colic Pain Management

Phase 4

Completed

• Conditions: Acute Pain Management; Renal Colic
• Interventions: Drug: Buprenorphine; Drug: Morphine

• Registration Number: NCT01546701
• Lead Sponsor: Tehran University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine	Buprenorphine	Renal Colic Patients treated by 2 mg sublingual Buprenorphine.
Morphine	Morphine	Renal Colic Patients treated by 0.1 mg/kg intravenous morphine.

Primary Outcome Measures

Name	Time	Method
change in pain score	20 and 40 minutes	change in pain severity based on Numerical Rating Score

Secondary Outcome Measures

Name	Time	Method
treatment side effects	40 minutes	experiencing any side effects by the patients as a result of treatment protocols.

Trial Locations

Locations (1)

TUMS; 🇮🇷 Tehran, Iran, Islamic Republic of