Evidence map›Paper›PMID 37953202›Full record

Trial reportBritish journal of anaesthesia2024

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.

Robert Bolt, Marie C Hyslop, Esther Herbert, Diana E Papaioannou, Nikki Totton, Matthew J Wilson, Janet Clarkson, Christopher Evans, Nicholas Ireland, Jennifer Kettle and 6 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in British journal of anaesthesia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 7 institutions in 1 country.

Robert BoltSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Marie C HyslopSheffield Clinical Trials Research Unit, ScHARR, University of Sheffield, Sheffield, UK.
Esther HerbertSheffield Clinical Trials Research Unit, ScHARR, University of Sheffield, Sheffield, UK.
Diana E PapaioannouSheffield Clinical Trials Research Unit, ScHARR, University of Sheffield, Sheffield, UK.
Nikki TottonSheffield Clinical Trials Research Unit, ScHARR, University of Sheffield, Sheffield, UK.
Matthew J WilsonSheffield School of Health & Related Research, University of Sheffield, Sheffield, UK.
Janet ClarksonDundee Dental Hospital and School, University of Dundee, Dundee, UK.
Christopher EvansUniversity College London Hospitals NHS Foundation Trust, London, UK.
Nicholas IrelandNewcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Jennifer KettleSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Zoe MarshmanSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Amy C NorringtonSouth Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
Robert H PatonBarnsley Hospital NHS Foundation Trust, Barnsley, UK.
Christopher VernazzaSchool of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.
Christopher DeerySchool of Clinical Dentistry, University of Sheffield, Sheffield, UK. Electronic address: c.deery@sheffield.ac.uk.
MAGIC collaborative
University of Sheffield · GBBarnsley Hospital NHS Foundation Trust · GBNewcastle University · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBSouth Tees Hospitals NHS Foundation Trust · GBUniversity College London Hospitals NHS Foundation Trust · GBUniversity of Dundee · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChild anxiety before general anaesthesia and surgery is common. Midazolam is a commonly used premedication to address this. Melatonin is an alternative anxiolytic, however trials evaluating its efficacy in children have delivered conflicting results.

methodsThis multicentre, double-blind randomised trial was performed in 20 UK NHS Trusts. A sample size of 624 was required to declare noninferiority of melatonin. Anxious children, awaiting day case elective surgery under general anaesthesia, were randomly assigned 1:1 to midazolam or melatonin premedication (0.5 mg kg

resultsThe trial was stopped prematurely (n=110; 55 per group) because of recruitment futility. Participants had a median age of 7 (6-10) yr, and 57 (52%) were female. Intention-to-treat and per-protocol modified Yale Preoperative Anxiety Scale-Short Form analyses showed adjusted mean differences of 13.1 (3.7-22.4) and 12.9 (3.1-22.6), respectively, in favour of midazolam. The upper 95% confidence interval limits exceeded the predefined margin of 4.3 in both cases, whereas the lower 95% confidence interval excluded zero, indicating that melatonin was inferior to midazolam, with a difference considered to be clinically relevant. No serious adverse events were seen in either arm.

conclusionMelatonin was less effective than midazolam at reducing preoperative anxiety in children, although the early termination of the trial increases the likelihood of bias. CLINICAL

trial registrationISRCTN registry: ISRCTN18296119.

Indexed as

MelatoninMidazolamAnesthesia, GeneralAnxietyChildDouble-Blind MethodFemaleHumansMalePremedicationMelatoninMidazolamgeneral anaesthesiamelatoninmidazolampaediatric anxietyperioperative carepremedication

Identifiers

PMID37953202
PMCPMC10797512
OpenAlexW4388576097

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.