Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic

February 15, 2009 updated by: Hadassah Medical Organization

Efficacy of Tramadol Hcl in the Treatment of Renal Colic

The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Renal stones is a common condition affecting up to 1% of the american population. The main symptom is renal colic. Acute treatment is based on the administration of analgesics mainly those belonging to non-steroidal antiinflammatory drugs (NSAIDs). Tramadol is an analgesic of the opioid class of analgesics (i.e morphine) and it is considered to cause less side effects with more or less the same analgesic potency. In the present study the analgesic effect of intramuscular Tramadol will be compared with Voltaren (NSAID)in patients attending the Emergency Department (ED) for acute renal colic (Stage I). Most of these patients will not pass their stone during their visit to the ED and they are prone to develop another attack of renal colic.In the second phase of the study (Stage II)patients who improved, and are ready to go home, will be enrolled to get Dipyrone or Tramadol orally for the prevention of further pain.

Study Type

Interventional

Enrollment (Anticipated)

100

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

  • Israel
      • Jerusalem, Israel, 12000
        • Hadassah Medical Organization

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with clinical diagnosis of acute renal colic (Stage I)
  • Patients with diagnosed renal colic who might need prevention of pain and are able to swallow medicines (Stage II)

Exclusion Criteria:

  • Patients with known hypersensitivity to the study drugs
  • Pregnancy or lactation
  • Known renal failure or hepatic disease
  • Concommitant drug use which could adversely affect patient's outcome (oral anticoagulant, MAO inhibitors)

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: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)
Time Frame: 30, 60, 120 minutes
30, 60, 120 minutes
Need for rescue medication at 30 minutes (Stage I)
Time Frame: 30 minutes
30 minutes
Pain improvement according to VAS score at 24 and 48 hrs (Stage II)
Time Frame: 24 and 48 hrs
24 and 48 hrs

Collaborators and Investigators

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

Sponsor

Hadassah Medical Organization

Collaborators

Grumental

Investigators

  • Principal Investigator: Ruth Stalnikowicz, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (Estimate)

April 5, 2006

Study Record Updates

Last Update Posted (Estimate)

February 17, 2009

Last Update Submitted That Met QC Criteria

February 15, 2009

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234567-HMO-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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