Researchers in Sheffield are to lead a first of its kind study investigating a new way of combating pre-operative anxiety in children who would not otherwise tolerate a general anaesthetic when undergoing planned ear, nose and throat (ENT) and dental surgeries.
The £1.65m study, with funding from the National Institute for Health Research, will be led by a team of researchers from Sheffield Teaching Hospitals, Sheffield Children's Hospital and the University of Sheffield across at least 10 UK sites.
It will be the first to specifically analyse whether a premedication known as melatonin can be used as a potential calmer in nervous children needing a general anaesthetic when having surgery for dental and ear, nose and throat-related problems.
Previous studies have focused on the experience of all children having ENT and dental surgeries rather than just ones who need a premedication to reduce anxiety.
Joined by researchers from Barnsley, Dundee, Liverpool and Manchester, the team will specifically seek to establish if melatonin has fewer side effects and can be offered as a safer alternative to the current recommended therapy, midazolam.
It will be the largest trial to date investigating the use of melatonin as a potential calmer in nervous children, which has been shown some success in reducing anxiety in adults undergoing general anaesthetic for surgery.
Around one in five to one in seven children need a medication to reduce anxiety ahead of planned ENT and dental surgeries. These two operations are the most common reasons for children to have an anaesthetic in the UK.
The study will seek to recruit over 600 parents/carers from at least 10 UK centres.
If melatonin is found to be a better premedication than midazolam, the researchers hope to change NHS policy.
Professor Chris Deery, a paediatric consultant at the School of Clinical Dentistry, University of Sheffield and Sheffield Teaching Hospitals Foundation Trust, said: “The hospital anaesthetic room can be a worrying place for a child, and reducing preoperative anxiety can have a huge impact on a child's hospital experience, improving recovery from the anaesthetic, reducing pain after surgery and avoiding the need for unnecessary reappointments and delays to operations.
“Although midazolam is an effective premedication for anxiety, it has many well known side effects, including loss of coordination and risks to breathing. Through this study we hope to improve the child's overall experience by establishing if a safer, alternative premedication can be offered.
“This major grant award exemplifies the excellent research collaboration that occurs between Sheffield Teaching Hospitals, Sheffield Children’s Hospital and the University of Sheffield, and affirms Sheffield as a leader of collaborative, multi-centred trials within the NHS.”
Dr Ayman Eissa, a consultant anesthetist at Sheffield Children's NHS Foundation Trust, added: “As a paediatric consultant in anaesthesia and pain medicine, reducing stress and anxiety in children is my main aim every day. I am looking forward to working as principal investigator with our partners in research and medicine on such an important and challenging research project. While this study is based Sheffield, it will run in many different centres all over the country, and its outcomes could positively impact children nationwide. We are hoping to start recruiting study sites in March this year.”
Both melatonin and midazolam are given to children as oral liquids, and are taken 30 to 40 minutes before surgery.
Jaimie Buckley, 40, of Crimicar Lane, Fulwood, said that her son Sam, now 10, was like a “new person” since having his tonsils taken out at the age of seven.
“I work in healthcare so I knew what to expect before he had his surgery and I could talk it through with him,” Jaimie, who works a specialist neonatal dietician, said. “Sam was relatively calm about the prospect of surgery so our experience wasn’t too stressful. Had he have been very anxious and upset, it would have been very hard to see him go through that. I'd give anything to recreate my experience for other parents, carers and children and since his operation Sam sleeps really well and has stopped coughing through the night.
“The MAGIC trial could be hugely important in addressing pre-operative anxiety in children and hopefully the results will enable anxious children to have a much calmer experience in hospital. Many children have the potential to benefit from this.”
The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial opens for recruitment in early 2019, with findings anticipated to be available in late 2020/early 2021.