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Buprenorphine in Acute Renal Colic Pain Management

This study has been completed.
Information provided by (Responsible Party):
Tehran University of Medical Sciences Identifier:
First received: March 1, 2012
Last updated: December 6, 2012
Last verified: December 2012
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.

Condition Intervention Phase
Acute Pain Management
Renal Colic
Drug: Buprenorphine
Drug: Morphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • change in pain score [ Time Frame: 20 and 40 minutes ]
    change in pain severity based on Numerical Rating Score

Secondary Outcome Measures:
  • treatment side effects [ Time Frame: 40 minutes ]
    experiencing any side effects by the patients as a result of treatment protocols.

Enrollment: 80
Study Start Date: March 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buprenorphine
Renal Colic Patients treated by 2 mg sublingual Buprenorphine.
Drug: Buprenorphine
2 mg sublingual tablet
Active Comparator: Morphine
Renal Colic Patients treated by 0.1 mg/kg intravenous morphine.
Drug: Morphine
0.1 mg/kg IV morphine


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01546701

Iran, Islamic Republic of
Tehran, Iran, Islamic Republic of, 1417613151
Sponsors and Collaborators
Tehran University of Medical Sciences
Study Director: Mohammad Jalili, MD TUMS
  More Information

Responsible Party: Tehran University of Medical Sciences Identifier: NCT01546701     History of Changes
Other Study ID Numbers: 130-1848
Study First Received: March 1, 2012
Last Updated: December 6, 2012

Additional relevant MeSH terms:
Acute Pain
Renal Colic
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Infant, Newborn, Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on April 27, 2017