Buprenorphine in Acute Renal Colic Pain Management

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Acute Pain Management; Renal Colic

Treatments: Drug: Morphine; Drug: Buprenorphine

Study type: Interventional

Funder types: Other

Identifiers

NCT01546701

130-1848

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Buprenorphine

Experimental group

Description:

Renal Colic Patients treated by 2 mg sublingual Buprenorphine.

Treatment:

Drug: Buprenorphine

Morphine

Active Comparator group

Description:

Renal Colic Patients treated by 0.1 mg/kg intravenous morphine.

Treatment:

Drug: Morphine