BACKGROUND: Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin METHODS: A case-based approach was used to identify barriers to recruitment. As part of a qualitative sub-study, semi-structured interviews with local site teams, participants, and caregivers also explored barriers and enablers to recruitment. RESULTS: Issues encountered included time sensitivity within pressured environments
feasibility of paediatric assent
research pharmacy availability
variation in anaesthetist equipoise
multifactorial decision-making issues in premedication selection
and the Associate Principal Investigator scheme being unable to support trials within anaesthetic trainee rotations. Future paediatric perioperative medicine trials could consider funding for research pharmacy outside of working hours
conducting risk assessments for study drugs to be held on theatre admission units
and a tailored design of site feasibility assessments to help address variation in practice. Challenges remain for the feasibility of including anaesthetic trainees within the Associate Principal Investigator scheme structure. CONCLUSIONS: There are significant challenges to recruitment for paediatric clinical trials in anaesthesia and perioperative medicine. The MAGIC trial highlighted variations within anaesthetic practice at individual, local, and regional levels. Lessons learned from the MAGIC trial identifies specific barriers to paediatric trial enrolment, offer solutions and discusses ongoing challenges. CLINICAL TRIAL REGISTRATION: ISRCTN registry: ISRCTN18296119.