Pain management in renal colic; The efficacy of continuous intravenous administration of tramadol versus butylscopolamine. A double blinded, randomized placebo controlled, prospective multicenter trial.
Phase 4
Withdrawn
- Conditions
- colic painrenal colic10046708
- Registration Number
- NL-OMON33885
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Adults 18 years and older
Written and oral informed consent obtained
Mental capacity to make a will
Exclusion Criteria
Pregnancy / lactation
Chronic tramadol use
Renal insufficiency, creatinine clearance < 10 ml/min
Hepatic insufficiency
Severe COPD / respiratory insufficiency
Intolerance to NSAID's and/or opioids
Monoamine oxidase inhibitors use, or within 2 weeks after withdrawal
Narrow-angle glaucoma
Intoxication with alcohol or other drugs
NSAID use < 8 hours before presentation
Hydronephrosis together with fever
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy of treatment is defined as a decline of 10 mm or more on the<br /><br>horizontal Visual Analogue Scale. Differences between the tramadol and<br /><br>butylscopolamine groups will be calculated with change in VAS-score between T0<br /><br>and T3(60 min)</p><br>
- Secondary Outcome Measures
Name Time Method