MAGIC trial

Melatonin for Anxiety prior to General anaesthesia In Children (MAGIC).

On
SCHARR - MAGIC logo

A multicentre, parallel randomised controlled trial of melatonin versus midazolam in the premedication of anxious children attending for elective dental, ophthalmologic or ear, nose and throat surgery under general anaesthesia.


Trial summary

Anxiety ahead of general anaesthesia is common, with up to 50% of children displaying manifestations of distress-behaviour at the point of anaesthetic induction.

Midazolam, the current standard premedication given to an anxious child ahead of surgery has been shown to be effective, although there are numerous adverse effects which make the medication less than ideal.

Melatonin offers many potential benefits over Midazolam.

MAGIC aims to compare the effectiveness and side effects of Melatonin versus Midazolam premedication, and to determine whether Melatonin offers sufficient benefit to warrant change in standard NHS practice.

Background

Dental extractions and tonsillectomies compose the two most common operations for children undergoing general anaesthesia in the UK, accounting for 60,000 and 34,000 operations per year, respectively.

Anxiety ahead of general anaesthesia is common, with up to 50% of children displaying manifestations of distress-behaviour at the point of anaesthetic induction.

Anxiety and distress in a child may lead to non-compliance and result in rescheduling of elective surgery; it may furthermore lead to greater post-operative pain, agitation and behavioural changes after surgery including sleep disturbances.

Midazolam, the current standard premedication given to an anxious child ahead of surgery has been shown to be effective, although there are numerous adverse effects which make the medication less than ideal.

One major consequence of benzodiazepine drugs such as midazolam is a sedative effect, which necessitates theatre transfer of the premedicated child, and also significantly delays post-operative recovery.

Further concerns include the potential for respiratory suppression and also unpredictable effects on children which may result in agitation rather than anxiolysis.

The increased incidence of learning disabilities with repeated anaesthetic exposure has been documented in a landmark study by Wilder et al., which highlighted the potential long-term risks of using sedative agents such as benzodiazepines in anaesthesia of young children.

The MAGIC trial

This study is to establish comparative effectiveness and side effect profile of melatonin versus midazolam as premedication in children aged 5-14 with high levels of preoperative distress prior to General Anaesthetic for Elective Dental, ophthalmologic, or ENT Surgery, and to determine whether melatonin offers sufficient benefit to warrant change in standard NHS practice.

Melatonin offers many potential benefits over midazolam.

These benefits may include greater paediatric acceptance of taste, walking rather than bed transfer from holding to theatre, improved postoperative analgesia, reduced postoperative sedation, reduced postoperative sleep disturbance, improved recovery times and avoidance of respiratory suppression.

Participants requiring Elective ENT and Dental Surgery Under General Anaesthesia in secondary/tertiary care centres will be recruited, and randomised in the ratio 1:1 to either the intervention arm (receiving melatonin 30 mins prior to general anaesthetic), or to usual care (midazolam 30 mins prior to general anaesthetic).

Both groups will be followed up for 14 days.


Recruitment updates

2nd April 2020

78 patients have been recruited and randomised to the trial.

Message from Professor Chris Deery (Chief Investigator): “It is very exciting to be getting going with the Trial at last. We have a great team and as you can imagine since being awarded the funding a lot of work has already been done".


Latest news

2nd January 2020

17 Sites are now open to recruitment:

Site Principal Investigator Contact details
Sheffield Dr Ayman Eissa A.eissa@nhs.net
Aberdeen Dr Graham Wilson graham.wilson@nhs.net
Liverpool Dr Nuria Masip Nuria.Masip@alderhey.nhs.uk
Croydon Dr Ashok Raj sundar.ashok@nhs.net
Doncaster Dr Padma Gopal padma.gopal@nhs.net
Newcastle Dr Christopher Vernazza Christopher.Vernazza@newcastle.ac.uk
Dundee Dr Simon Crawley simoncrawley@nhs.net
Sunderland Dr Sean Cope Sean.Cope@chsft.nhs.uk
Middlesbrough Dr Amy Norrington amy.norrington@nhs.net
Darlington Dr James Limb j.limb@nhs.net
Kilmarnock Dr Tim Geary t.geary@nhs.net
Bolton Dr Rachel Smith rachel.smith@boltonft.nhs.uk
Glasgow Dr Tony Moores Tony.Moores@ggc.scot.nhs.uk
Stoke-on-Trent Dr Maggie Babb Maggie.Babb@uhnm.nhs.uk
Barnsley Dr Hamish Paton robert.paton@nhs.net
Manchester Dr Sian Rolfe sian.rolfe@mft.nhs.uk
Stevenage Dr Pranav Kukreja pranav.kukreja@nhs.net

Funder

This project is funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme (project number 16/80/08). Any views or opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.


Sheffield Teaching Hospitals NHS Foundation Trust


Study contacts

Name Role Organisation Contact
Professor Chris Deery Chief Investigator School of Clinical Dentistry c.deery@sheffield.ac.uk
Dr Robert Bolt Co-Investigator School of Clinical Dentistry r.bolt@sheffield.ac.uk
Dr Ayman Eissa Lead Anaesthetist Sheffield Children's Hospital ayman.eissa@sch.nhs.uk
Katie Biggs Study Lead CTRU, University of Sheffield c.e.biggs@sheffield.ac.uk
Marie Hyslop Study Manager CTRU, University of Sheffield m.c.hyslop@sheffield.ac.uk
Elena Sheldon Research Assistant CTRU, University of Sheffield e.m.sheldon@sheffield.ac.uk
Louise Turner Trial Support Officer CTRU, University of Sheffield louise.turner@sheffield.ac.uk
Nikki Totton Statistician CTRU, University of Sheffield n.totton@sheffield.ac.uk
Esther Herbert Statistician CTRU, University of Sheffield e.herbert@sheffield.ac.uk
Amanda Loban Data Management CTRU, University of Sheffield a.loban@sheffield.ac.uk
Tracey Young Health Economist HEDS, University of Sheffield t.a.young@sheffield.ac.uk

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