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

This study has been completed.
Sponsor:
Collaborator:
Grumental
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00310908
First received: April 4, 2006
Last updated: February 15, 2009
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Renal Calculus
Drug: Tramadol Hcl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Tramadol Hcl in the Treatment of Renal Colic

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I) [ Time Frame: 30, 60, 120 minutes ] [ Designated as safety issue: No ]
  • Need for rescue medication at 30 minutes (Stage I) [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
  • Pain improvement according to VAS score at 24 and 48 hrs (Stage II) [ Time Frame: 24 and 48 hrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tramadol Hcl
    Active Comparator
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00310908

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 12000
Sponsors and Collaborators
Hadassah Medical Organization
Grumental
Investigators
Principal Investigator: Ruth Stalnikowicz, MD Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Ruth Stalnikowicz, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00310908     History of Changes
Other Study ID Numbers: 1234567-HMO-CTIL
Study First Received: April 4, 2006
Last Updated: February 15, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Renal
Colic
Calculi
Treatment

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Renal Colic
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014