A randomised controlled trial of a continuous butylscopolamine infusion versus a placebo infusion in patients with a renal colic not responding to oral NSAIDs

The buscopan study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29114

Enrollment

128

Registered

2019-06-21

Start date

2018-01-13

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Urolithiasis

Interventions

At the start all patients wil receive 1000 mg paracetamol 4 times daily and 50 mg Diclofenac 3 times daily if they haven’t taken or received these earlier. Group A will be given butylscopolamine 100 m

Eligibility

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 100/min - Ischemic heart disease - Heart failure - Severe aortic valve stenosis

Design outcomes

Primary

Measure	Time frame
The primary outcome in this study is the amount of escape medication used during the 24-hour period of observation, measured in units.	—

Secondary

Measure	Time frame
• 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. • 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) • Interventions necessary because of ongoing pain • Time until last escape medication is given	—

Measure

Time frame

• 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. • 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) • Interventions necessary because of ongoing pain • Time until last escape medication is given

—

Contacts

Public ContactSaskia Weltings

Haga ziekenhuis

saskiaweltings@gmail.com0031645958501

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)