# A Comprehensive Review of the Effects of Hyoscine Butylbromide in Childhood

## TL;DR

This paper reviews the use of hyoscine butylbromide in children, finding it safe and effective for various conditions, though more studies are needed.

## Contribution

The paper provides a comprehensive review of HBB's efficacy and safety in both approved and off-label uses in children.

## Key findings

- HBB shows similar efficacy to paracetamol for abdominal cramps in children.
- HBB is safe for infants and children younger than the approved age of 6 years.
- There is strong evidence supporting HBB's safety in off-label uses like general anesthesia and childbirth.

## Abstract

Background/Objectives: Hyoscine butylbromide (HBB) is a spasmolytic drug classified as indispensable by the World Health Organization. While mostly used in adults, it is also approved for use in adolescents and children aged 6 years and older. We have comprehensively reviewed the efficacy and safety of HBB in approved and off-label childhood indications. Results: Childhood studies covered an age range starting as early as 2 days. A randomized controlled trial (RCT) found a similar efficacy compared to paracetamol in the approved indication of abdominal cramps and pain. Among off-label uses, several studies demonstrate efficacy in general anesthesia and various diagnostic procedures, but the largest body of evidence relates to use in childbirth/labor, including 17 RCTs. While these largely focused on efficacy outcomes on the mother, fetal safety outcomes were reported in 12 of these studies, mostly as effects on the APGAR score and/or heart rate. The overall evidence supports safety in infants and children including those younger than the approved use age of 6 years and older. Conclusions: While only limited pediatric efficacy data from RCTs are available in the approved indications, data from thousands of patients in RCTs, case series, and non-randomized trials do not raise concerns on the safety and tolerability of HBB in childhood. Additional dedicated childhood studies, particularly RCTs, on efficacy are recommended.