Melatonin for Anxiety prior to General anaesthesia In Children (MAGIC)
Research type
Research Study
Full title
The MAGIC trial (Melatonin for Anxiety prior to General anaesthesia In Children): A Multicentre, Parallel Randomised Controlled Trial of Melatonin Versus Midazolam in the Premedication of Anxious Children Attending for Elective Dental, Ophthalmologic or ENT Surgery Under General Anaesthesia
IRAS ID
228234
Contact name
Chris Deery
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2018-000991-13
Duration of Study in the UK
1 years, 6 months, 14 days
Research summary
Midazolam is an effective premedication in anxious children undergoing general anaesthesia, however it can have considerable adverse effects. Adverse effects include respiratory suppression, agitation, sedation, delayed recovery, post-operative sleep disturbance and nausea/vomiting. There is therefore a need for a safer medication which is as effective at reducing anxiety to midazolam.
Melatonin has been found to be as effective as midazolam in the management of pre-operative anxiety in adults, although its effectiveness in children is not confirmed. A major flaw in previous trials relates to comparing a general pre-operative child group rather than selecting for specifically-anxious children; the effects of both melatonin and any comparator are therefore weakened by those children who would not have normally been selected for premedication ahead of surgery.
Melatonin has an excellent side-effects profile, and may have further advantages over midazolam in that it reduces anxiety without sedation, reduces pain and improves post-discharge sleep disturbance. In order to assess melatonin’s effectiveness in anxious children ahead of general anaesthesia, a pragmatic, randomised controlled trial comparing it against the current standard, midazolam, is required.
We will also be hosting a Study Within A Trial (SWAT) whereby participants will be randomised to either a standard or personalised text message reminder for their 14 day follow up call to see what impact, if any, the personalised message has on retention rates. The SWAT is detailed in a separate protocol.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0758
Date of REC Opinion
16 Jan 2019
REC opinion
Further Information Favourable Opinion