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

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.

Study Updates

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.

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

COVID-19 Update May 2020

The current COVID-19 coronavirus pandemic has lead to numerous pressures and changes, both for the NHS and research, the most recent of which included the cancellation of all routine elective surgeries within the UK and the prioritisation of COVID-19 studies.

Many sites have chosen to halt recruitment to the MAGIC trial already. In light of these extraordinary circumstances, we have decided to pause recruitment to the MAGIC trial until further notice.

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

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