Pain management in renal colic; The efficacy of continuous intravenous administration of tramadol versus butylscopolamine. A double blinded, randomized placebo controlled, prospective multicenter trial. - TraBu-trial

Conditions: Renal colic pain based on kidney or ureteric stones in patients of 18 years and older.

Registration Number: EUCTR2007-006198-98-NL

Lead Sponsor: Isala klinieken Zwolle

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

The participants are 18 years and older and are able to make a will. Participants presenting with clinical signs and symptoms of renal colic, as ajudged by a urologist or resident in urology, are included after oral an written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-pregnancy or lactation
-chronic tramadol use
-severe renal failure, GFR less than 10 ml/min
-severe hepatic failure
-allergic reactions to opioids / NSAID's
-concommitent use of MAO-inhibitor, or less than 2 weeks after stop MAO-inhibitor
-narrow-angle glaucoma
-use of NSAID's 8 hours before admittance
-use of drugs or alcohol 8 hours before admittance
-hydronephrotic kidney combined with fever

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Can a difference between the change in the perception of pain over time(0-60minutes) between tramadol and butylscopolamine in renal colic be proven?;Secondary Objective: -Can a difference in the decline in VAS-score over time (0-240min) between the tramadol group and the butylscopolamine group be proven?<br>-Can the therapeutic efficacy of butylscopolamine compared to placebo over time (0-240min) be proved?<br>-Can the therapeutic efficacy of tramadol compared to placebo over time (0-240min) be proved?<br>-What are the side effects of continuous intravenous administered tramadol and to what extend do they occur?<br>-Is a difference in the need for of rescue-medication seen between the tramadol and butylscopolamine group?;Primary end point(s): Efficacy of treatment is defiend as a decline of 10mm or more on the horizontal Visual Analogue Scale. Differences between the tramadol and butylscopolamine groups wil be calculated with change in VAS-score between T0 and T3 ( 60min ).

Secondary Outcome Measures