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Buprenorphine in Acute Renal Colic Pain Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01546701
First received: March 1, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • change in pain score [ Time Frame: 20 and 40 minutes ] [ Designated as safety issue: No ]
    change in pain severity based on Numerical Rating Score


Secondary Outcome Measures:
  • treatment side effects [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546701

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

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01546701     History of Changes
Other Study ID Numbers: 130-1848
Study First Received: March 1, 2012
Last Updated: December 6, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Additional relevant MeSH terms:
Renal Colic
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Buprenorphine
Morphine
Analgesics, Opioid
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013