Evidence map›Paper›PMID 39991707›Full record

ArticleBJA open2025

Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial).

Marie C Hyslop, Diana E Papaioannou, Robert Bolt, Matthew J Wilson, Michael Bradburn, Janet Clarkson, Esther Herbert, Nicholas Ireland, Jennifer Kettle, Amanda Loban and 3 more

Abstract read
In one paragraph

Article in BJA open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Marie C HyslopSheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UK.
Diana E PapaioannouSheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UK.
Robert BoltSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Matthew J WilsonSheffield Centre for Health & Related Research (SCHARR), University of Sheffield, Sheffield, UK.
Michael BradburnSheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UK.
Janet ClarksonDundee Dental Hospital and School, University of Dundee, Dundee, UK.
Esther HerbertSheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UK.
Nicholas IrelandNewcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Jennifer KettleSchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Amanda LobanSheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UK.
Amy C NorringtonSouth Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
Christopher VernazzaSchool of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK.
Christopher DeerySchool of Clinical Dentistry, University of Sheffield, Sheffield, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin Methods: A case-based approach was used to identify barriers to recruitment. As part of a qualitative sub-study, semi-structured interviews with local site teams, participants, and caregivers also explored barriers and enablers to recruitment. Results: Issues encountered included time sensitivity within pressured environments; feasibility of paediatric assent; research pharmacy availability; variation in anaesthetist equipoise; multifactorial decision-making issues in premedication selection; and the Associate Principal Investigator scheme being unable to support trials within anaesthetic trainee rotations. Future paediatric perioperative medicine trials could consider funding for research pharmacy outside of working hours; conducting risk assessments for study drugs to be held on theatre admission units; and a tailored design of site feasibility assessments to help address variation in practice. Challenges remain for the feasibility of including anaesthetic trainees within the Associate Principal Investigator scheme structure. Conclusions: There are significant challenges to recruitment for paediatric clinical trials in anaesthesia and perioperative medicine. The MAGIC trial highlighted variations within anaesthetic practice at individual, local, and regional levels. Lessons learned from the MAGIC trial identifies specific barriers to paediatric trial enrolment, offer solutions and discusses ongoing challenges. Clinical trial registration: ISRCTN registry: ISRCTN18296119.

Indexed as

early termination of clinical trialsgeneral anaesthesiapaediatric anxietyperioperative carepoor recruitmentreasons for recruitment failure

Identifiers

PMID39991707
PMCPMC11847519

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Registered trials

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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 OpenQuestion graph.