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

Hadassah Medical Center

Status and phase

Completed

Phase 4

Conditions

Renal Calculus

Treatments

Drug: Tramadol Hcl

Study type

Interventional

Funder types

Other

Identifiers

NCT00310908

1234567-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)