# A cost-effectiveness analysis of melatonin in comparison with midazolam for anxiety prior to general anaesthesia in children: the MAGIC randomised controlled trial (melatonin for anxiety prior to general anaesthesia in children)

## TL;DR

This study compared the cost-effectiveness of melatonin and midazolam for reducing anxiety in children before surgery but found inconclusive results due to limited data.

## Contribution

The first study to evaluate the cost-effectiveness of melatonin versus midazolam for preoperative anxiety in children.

## Key findings

- Melatonin was associated with lower average costs over 14 days compared to midazolam, but the difference was not statistically significant.
- No evidence was found that melatonin was more cost-effective than midazolam in terms of cost per QALY.
- The study was limited by early closure and low recruitment, reducing statistical power.

## Abstract

To date no study has looked at the cost-effectiveness of melatonin for anxiety prior to general anaesthetic in children or young people. The aim of the health economic analysis was to evaluate the within trial cost-effectiveness of melatonin for anxiety in children compared to usual care (midazolam) prior to general anaesthesia in children from an NHS and Personal Social Services perspective.

The economic evaluation was undertaken alongside a multicentre randomised controlled trial (MAGIC). Children were individually randomised to receive either melatonin or midazolam for anxiety prior to general anaesthesia. Resource use was collected from case-record forms. Children were followed up at 14 days post-surgery. The main outcome was the incremental cost per successful procedure. The trial was closed early due to recruitment futility, which limited the studies statistical power.

A total of 100 children received the Investigational Medicinal Product (IMP) treatment, 50 receiving melatonin and 50 receiving midazolam, these were the focus of the health economic analysis. On average, costs over 14 days were lower for those who received melatonin (-£46.20, 95% CI: -£166.14 to £66.74) with a mean incremental difference in procedure success of -0.02 (95% CI –0.08 to 0.004), though there was uncertainty around the results. There was no evidence of either treatment being cost-effective in a cost per QALY analysis using the CHU-9D (-£46.20, 95% CI: -£166.142 to £66.74) with a mean incremental QALY -0.0001 (95% CI –0.0008 to 0.0008). Subgroup analysis was limited to those who underwent head and neck procedures owing to small numbers by subgroup for other procedure types and age group and results were similar to the main analysis.

This is the first study to examine the cost-effectiveness of melatonin in comparison with midazolam in children. The results were inconclusive showing no evidence that melatonin was more cost-effective than midazolam. The study closed early owing to issues with recruitment, which reduced the studies statistical power, and this has limited the economic analysis.

Registered with the UK Clinical Study Registry ISRCTN18296119 on 10/01/2019.

The online version contains supplementary material available at 10.1186/s12871-025-03489-x.