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

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 - BUSCOPAN

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47573

Enrollment

128

Registered

2017-08-11

Start date

2018-01-13

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urolithiasis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results