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

Rationale: 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 formulated 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.
Objective The purpose of this study is to prove that treatment with placebo intravenously is noninferior
to treatment with butylscopolamine in a continuous intravenous infusion when treating
patients with renal colics not responding to oral NSAIDs.
Study design: A double blind placebo controlled, multicenter, randomised controlled clinical trial
Study population: The patient population consists of adults presenting with a renal colic, diagnosed
by ultrasound or CT-scan, not responding to oral NSAIDs and therefore admitted to the urological
ward for pain medication.
Intervention: Patients are randomized in one of two study-arms. They will receive either
butylscopolamine in a continuous infusion or saline in a continuous infusion. Both groups have the
availability of piritramide injections as escape medication aiming for a score of 0 on NRS scale.
Main study parameters/endpoints: The primary endpoint is the amount of escape medication during
the 24-hour period of observation in units.
The secondary endpoints are pain reduction in Numerice Rating Scale score (NRS score), the side
effects of the different medications, rate of interventions and time until last need for escape
medication.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Patients have to fill in a NRS score and a questionnaire about the side effects 5 times.
They will all have the possibility to use escape medication and will therefore be treated adequately
for their pain. The main risk is the possible need for more escape medication and the associated side
effects. All medications used are already registered and clinicaly widely used for this indication.

Null hypothesis: placebo is non-inferior to continuous intravenous infusion with buscopan in terms of
amount of escape medication used in patients admitted for renal colic.

24 hours

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 mg
in 24 hours via an intravenous continuous infusion. Group B will receive saline in 24 hours via an
intravenous continuous infusion.
NRS scores are documented at at 0 hours, 1 hours, 4 hours, 8 hours and 24 hours. Escape medication
is used to maintain adequate pain relief. A pain score below 4 is accepted as adequate pain
management. After 24 hours, the study period ends and giving standard of care is continued.