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Buprenorphine in Acute Renal Colic Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01546701
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : December 10, 2012
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE March 1, 2012
First Posted Date  ICMJE March 7, 2012
Last Update Posted Date December 10, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2012)
change in pain score [ Time Frame: 20 and 40 minutes ]
change in pain severity based on Numerical Rating Score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2012)
treatment side effects [ Time Frame: 40 minutes ]
experiencing any side effects by the patients as a result of treatment protocols.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buprenorphine in Acute Renal Colic Pain Management
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pain Management
  • Renal Colic
Intervention  ICMJE
  • Drug: Buprenorphine
    2 mg sublingual tablet
  • Drug: Morphine
    0.1 mg/kg IV morphine
Study Arms  ICMJE
  • Experimental: Buprenorphine
    Renal Colic Patients treated by 2 mg sublingual Buprenorphine.
    Intervention: Drug: Buprenorphine
  • Active Comparator: Morphine
    Renal Colic Patients treated by 0.1 mg/kg intravenous morphine.
    Intervention: Drug: Morphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2012)
80
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2012)
60
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01546701
Other Study ID Numbers  ICMJE 130-1848
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohammad Jalili, MD TUMS
PRS Account Tehran University of Medical Sciences
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP