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Completed

NCT Number: NCT00310908

Comparison Between Tramadol Hcl and Other Analgesics 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.

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Key information

Conditions

Renal Calculus Calculi Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hadassah Medical Organization

Jerusalem, 12000, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tramadol HCl

Drug

Active Comparator

Primary outcomes

  1. Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)

    Time frame: 30, 60, 120 minutes

  2. Need for rescue medication at 30 minutes (Stage I)

    Time frame: 30 minutes

  3. Pain improvement according to VAS score at 24 and 48 hrs (Stage II)

    Time frame: 24 and 48 hrs

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Grumental

Registry information

Official study title

Efficacy of Tramadol Hcl in the Treatment of Renal Colic

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 5, 2006
Registry last updated
Feb 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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