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

Renal Calculus Clinical Trial

Official title:

Efficacy of Tramadol Hcl in the Treatment of Renal Colic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310908
• Other study ID #: 1234567-HMO-CTIL
• Status: Completed
• Phase: Phase 4
• First received: April 4, 2006
• Last updated: February 15, 2009
• Start date: September 2006
• Est. completion date: February 2009

Study information

• Verified date: September 2006
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Calculus
• Renal Colic

Intervention

Drug:
• Tramadol Hcl
Active Comparator

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Grumental

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Ukhal' MI, Melenevskii DA. [Using prostaglandin inhibitor dicloberl in patients with ureteral calculi]. Lik Sprava. 2004 Mar;(2):76-8. Russian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)		30, 60, 120 minutes	No
Primary	Need for rescue medication at 30 minutes (Stage I)		30 minutes	Yes
Primary	Pain improvement according to VAS score at 24 and 48 hrs (Stage II)		24 and 48 hrs	Yes