Study protocol for a randomized clinical trial of a continuous butylscopolamine infusion versus a placebo in patients with a renal colic not responding to oral NSAIDs

Phase 4

Completed

• Conditions: urolithiasis; 10046708

• Registration Number: NL-OMON47573
• Lead Sponsor: HagaZiekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-11-07
• Results First Posted: 2020-05-19
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 128

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the pain reduction in Numerice Rating Scale score (NRS<br /><br>score), measured at at 0 hours, 1 hours, 4 hours, 8 hours and 24 hours. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are the side effects of the different medications, the<br /><br>amount of rescue medication, the rate of interventions in patients not<br /><br>responding to the medication therapy and the time until last escape medication<br /><br>is given</p><br>