The purpose of this study is to analyse the effect on pain reduction of butylscopolamine in a continuous intravenous infusion compared to a placebo in patients with renal colics not responding to oral NSAIDs.
ID
Source
Brief title
Condition
- Urolithiases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the pain reduction in Numerice Rating Scale score (NRS
score), measured at at 0 hours, 1 hours, 4 hours, 8 hours and 24 hours.
Secondary outcome
The secondary endpoints are the side effects of the different medications, the
amount of rescue medication, the rate of interventions in patients not
responding to the medication therapy and the time until last escape medication
is given
Background summary
A renal colic is an excruciating pain which is often difficult to control.
Tailored analgesia in patients not responding to oral Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs) is a therapeutic challenge. There is a variety
of analgesic regimes worldwide. In the Netherlands these patients are admitted
to the hospital and are traditionally treated with a continuous perfusion of
butylscopolamine. However recently, the Dutch Association of Urology together
with patient organisations produced a document on clinical knowledge gaps
relevant for the daily urological practice. One of the knowledge gaps mentioned
was the lack of scientific evidence for the effiency of butylscopolamine in
renal colics. The Netherlands is one of few countries where butylscopolamine is
widely used empirically to reduce renal colics.
Study objective
The purpose of this study is to analyse the effect on pain reduction of
butylscopolamine in a continuous intravenous infusion compared to a placebo in
patients with renal colics not responding to oral NSAIDs.
Study design
A double blind placebo controlled, multicenter, randomized clinical trial
Study burden and risks
Patients are asked to fill out a questionnary 5 times
Leyweg 275
Den Haag 2545 CH
NL
Leyweg 275
Den Haag 2545 CH
NL
Listed location countries
Age
Inclusion criteria
• 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.
Exclusion criteria
• 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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR39.560.058.12-NL |
| CCMO | NL56469.098.17 |