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

Primary Purpose

Renal Calculus

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Tramadol Hcl
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Calculus focused on measuring Renal, Colic, Calculi, Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Hadassah Medical Organization

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
April 4, 2006
Last Updated
February 15, 2009
Sponsor
Hadassah Medical Organization
Collaborators
Grumental
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1. Study Identification

Unique Protocol Identification Number
NCT00310908
Brief Title
Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic
Official Title
Efficacy of Tramadol Hcl in the Treatment of Renal Colic
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization
Collaborators
Grumental

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculus
Keywords
Renal, Colic, Calculi, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tramadol Hcl
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
Pain improvement according to VAS score at 30, 60 and 120 minutes(Stage I)
Time Frame
30, 60, 120 minutes
Title
Need for rescue medication at 30 minutes (Stage I)
Time Frame
30 minutes
Title
Pain improvement according to VAS score at 24 and 48 hrs (Stage II)
Time Frame
24 and 48 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Stalnikowicz, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
12000
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
15208882
Citation
Ukhal' MI, Melenevskii DA. [Using prostaglandin inhibitor dicloberl in patients with ureteral calculi]. Lik Sprava. 2004 Mar;(2):76-8. Russian.
Results Reference
result

Learn more about this trial

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

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