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Buprenorphine in Acute Renal Colic Pain Management

NCT ID: NCT01546701

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-04-30

Brief Summary

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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

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Conditions

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Acute Pain Management Renal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Buprenorphine

Renal Colic Patients treated by 2 mg sublingual Buprenorphine.

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

2 mg sublingual tablet

Morphine

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

0.1 mg/kg IV morphine

Interventions

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Buprenorphine

2 mg sublingual tablet

Intervention Type DRUG

Morphine

0.1 mg/kg IV morphine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Jalili, MD

Role: STUDY_DIRECTOR

TUMS

Locations

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TUMS

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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130-1848

Identifier Type: -

Identifier Source: org_study_id