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Buprenorphine in Acute Renal Colic Pain Management

Primary Purpose

Acute Pain Management, Renal Colic

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Buprenorphine
Morphine
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain Management

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • TUMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Buprenorphine

Morphine

Arm Description

Renal Colic Patients treated by 2 mg sublingual Buprenorphine.

Renal Colic Patients treated by 0.1 mg/kg intravenous morphine.

Outcomes

Primary Outcome Measures

change in pain score
change in pain severity based on Numerical Rating Score

Secondary Outcome Measures

treatment side effects
experiencing any side effects by the patients as a result of treatment protocols.

Full Information

First Posted
March 1, 2012
Last Updated
December 6, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01546701
Brief Title
Buprenorphine in Acute Renal Colic Pain Management
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain Management, Renal Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buprenorphine
Arm Type
Experimental
Arm Description
Renal Colic Patients treated by 2 mg sublingual Buprenorphine.
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Renal Colic Patients treated by 0.1 mg/kg intravenous morphine.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
2 mg sublingual tablet
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
0.1 mg/kg IV morphine
Primary Outcome Measure Information:
Title
change in pain score
Description
change in pain severity based on Numerical Rating Score
Time Frame
20 and 40 minutes
Secondary Outcome Measure Information:
Title
treatment side effects
Description
experiencing any side effects by the patients as a result of treatment protocols.
Time Frame
40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Jalili, MD
Organizational Affiliation
TUMS
Official's Role
Study Director
Facility Information:
Facility Name
TUMS
City
Tehran
ZIP/Postal Code
1417613151
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Buprenorphine in Acute Renal Colic Pain Management

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