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)
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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