Pediatric anesthesia & critical care
The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia
- stopped prematurely for recruitment futility
- Stopped prematurely because of recruitment futility (624 required)
Authors' conclusion
Melatonin was less effective than midazolam at reducing preoperative anxiety in children, although the early termination of the trial increases the likelihood of bias.
Study context
- Population
- Anxious children awaiting day case elective surgery under GA, 20 UK NHS Trusts624 planned
- Participants
- 110 children
- Comparison
- Melatonin vs Midazolam
- Melatoninn = 55
- Midazolamn = 55reference
- Primary endpoint
- Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF)
Methodological detailspragmatic, multicentre, parallel, noninferiority, double-blind
- Pragmatic
- Multicentre
- Parallel
- Noninferiority
- Double-blind
Primary result
As reported in the abstract
mYPAS-SF
Melatonin vs MidazolamAdjusted MD (95% CI)
ITT; in favour of midazolam
13.1(3.7–22.4)
Per-protocol; in favour of midazolam
12.9(3.1–22.6)
Non-inferiority margin 4.3 as printed, not drawn
Safety
Events
| Outcome | Melatonin | Midazolam |
|---|---|---|
| Serious adverse events | 0 | 0 |
Original publication
The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia. Br J Anaesth. Published 10 November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →