Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic
Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Calculus
Intervention: Tramadol Hcl (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s):
Ruth Stalnikowicz, MD, Principal Investigator, Affiliation: Hadassah Medical Organization, Jerusalem, Israel
Overall contact:
Ruth Stalnikowicz, MD, Phone: 00 972-2-5844366, Email: darvasi@md.huji.ac.il
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.
Clinical Details
Official title: Efficacy of Tramadol Hcl in the Treatment of Renal Colic
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)Need for rescue medication at 30 minutes (Stage I) Pain improvement according to VAS score at 24 and 48 hrs (Stage II)
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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)
Locations and Contacts
Ruth Stalnikowicz, MD, Phone: 00 972-2-5844366, Email: darvasi@md.huji.ac.il
Hadassah Medical Organization, Jerusalem 12000, Israel; Recruiting
Arik Tzukert, DMD, Phone: 00972 2 6776095, Email: arik@hadassah.org.il
Hadas Lemberg, Phd, Phone: 00 972 26777572, Email: lhadas@hadassah.org.il
Ruth Stalnikowicz, MD, Principal Investigator
Additional Information
Starting date: September 2006
Ending date: December 2008
Last updated: July 8, 2008
|
