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 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 3-14 with high levels of preoperative distress prior to General Anaesthetic for Elective 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 dental, ophthalmological, ENT, gastroenterology, radiology, plastic, orthopaedic, urology, or other general surgeries 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.


Participating sites

Site

Principal Investigator

Status

Aberdeen

Gil Gavel

Open

Barnsley

Hamish Paton

Open

Bolton

Rachel Smith

Open

Doncaster

Padma Gopal

Open

Dundee

Simon Crawley

In set-up

East Grinstead

Ed Pickles

Open

Fife

Ian Leeuwenberg

Open

Glasgow

Tony Moores

In set-up

Kilmarnock

Tim Geary

Open

Kings

Natasha Woodman

In set-up

Manchester

Vimmi Oshan

In set-up

Medway

Samantha Black

In set-up

Middlesbrough

Amy Norrington

Open

Newcastle

Christopher Vernazza

Open

Royal Berkshire

Dana Kelly

In set-up

ºù«Ӱҵ

Claire Biercamp

Open

Sherwood

Puran Khandelwal

Open

Shrewsbury

Karthikeyan Selvaraju

In set-up

Stevenage

Pranav Kukreja

Open

Sunderland

Sean Cope

Open

Walsall

Klaus Mahler

In set-up

Whipps Cross

Robert McCartney

In set-up


Latest news

September 2022

Welcome back to the MAGIC trial Chief Investigator, Professor Chris Deery.


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.


Sponsor

ºù«Ӱҵ 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
Professor Matt Wilson Co-Investigator/Lead Anaesthetist ScHARR, University of ºù«Ӱҵ m.j.wilson@sheffield.ac.uk
Dr Robert Bolt Co-Investigator School of Clinical Dentistry r.bolt@sheffield.ac.uk
Marie Hyslop Study Manager CTRU, University of ºù«Ӱҵ m.c.hyslop@sheffield.ac.uk
Kate Hutchence Research Assistant CTRU, University of ºù«Ӱҵ k.j.hutchence@sheffield.ac.uk
Adam Lloyd Trial Support Officer CTRU, University of ºù«Ӱҵ adam.lloyd@sheffield.ac.uk
Amanda Loban Data Management CTRU, University of ºù«Ӱҵ a.loban@sheffield.ac.uk
Richard Simmonds Data Management CTRU, University of ºù«Ӱҵ r.p.simmonds@sheffield.ac.uk
Tracey Young Health Economist HEDS, University of ºù«Ӱҵ t.a.young@sheffield.ac.uk
Diana Papaioannou CTRU Lead CTRU, University of ºù«Ӱҵ d.papaioannou@sheffield.ac.uk
Esther Herbert Medical
Statistician
CTRU, University of ºù«Ӱҵ e.herbert@sheffield.ac.uk

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MAGIC Protocol

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