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Buprenorphine in Acute Renal Colic Pain Management

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ClinicalTrials.gov Identifier: NCT01546701
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : December 10, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Pain Management Renal Colic Drug: Buprenorphine Drug: Morphine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01546701     History of Changes
Other Study ID Numbers: 130-1848
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 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