A randomised controlled trial of a continuous butylscopolamine infusion versus a placebo infusion in patients with a renal colic not responding to oral NSAIDs
- Conditions
- rolithiasis
- Registration Number
- NL-OMON29114
- Lead Sponsor
- Haga teaching hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 128
Legally capable and competent to understand the implications of participation in the study and signed informed consent
Age 18 years or older
Presentation with renal colic confirmed by ultrasound or CT-scan, not responding to oral NSAIDs and therefore admitted to the urological ward for pain medication.
• Pregnancy or lactation
• Known allergy to any of the products used
• Contra-indication for NSAIDs
• Diagnosis other than renal colic
• Patients presenting with a temperature > 38.5°C at time of inclusion or <24 hours ago
• Patients with antibiotic for UTI together with urolithiasis or urolithiasis with indication for
drainage of the upper urinary tract
• Any of the following conditions:
- Megacolon
- Intestinal mechanical stenoses
- Myasthenia gravis
- Untreated narrow angle glaucoma
- Epilepsy
- Alcohol or drugs intoxication
- Creatinin clearance < 30 ml/min
- Atrial fibrillation with heart rate > 100/min
- Ischemic heart disease
- Heart failure
- Severe aortic valve stenosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome in this study is the amount of escape medication used during the 24-hour<br>period of observation, measured in units.
- Secondary Outcome Measures
Name Time Method • Pain reduction in Numerice Rating Scale score (NRS score). NRS scores are documented at at 0 hours, 1 hours, 4 hours, 8 hours and 24 hours.<br>• Side effects of buscopan and side effects of the escape medication Extra medication needed to treat possible side effects of the study medication (nausea, vomiting)<br>• Interventions necessary because of ongoing pain<br>• Time until last escape medication is given