Buprenorphine in Acute Renal Colic Pain Management

December 6, 2012 updated by: Tehran University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pain score
Time Frame: 20 and 40 minutes
change in pain severity based on Numerical Rating Score
20 and 40 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment side effects
Time Frame: 40 minutes
experiencing any side effects by the patients as a result of treatment protocols.
40 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Director: Mohammad Jalili, MD, TUMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130-1848

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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