Abstract
BACKGROUND: The acceptability of a children's premedication, prior to general anaesthesia (GA), is fundamental to ensuring positive clinical- and patient-reported outcomes. Midazolam, the current standard premedication, is known to have an unfavourable side-effects profile and presents a degree of risk which is accepted due to a need for compliance. Melatonin is a functionally diverse hormone with anxiolytic properties that offer potential benefits over midazolam. Little is currently known about how patients and health professionals view these two different premedications. This research aimed to explore the acceptability of midazolam and melatonin as premedications for anxious children undergoing GA, from the perspective of children, caregivers and health professionals involved in the Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial. METHODS: Participants were children recruited to the MAGIC trial, their caregivers and health professionals involved in recruitment to the trial. In total, 37 participants (23 health professionals, 10 caregivers and 4 children) took part in semi-structured interviews relating to the MAGIC trial and acceptability of premedications. Interviews were carried out face-to-face, by telephone or online by a trained qualitative researcher. Interviews were transcribed verbatim and analysed using a framework approach. RESULTS: The acceptability of midazolam and melatonin is related to six main factors: effectiveness as premedication prior to GA; administration of premedication; experience of recovery; prior experiences of premedication; associations and evidence; and range of options for managing anxiety. Interviews highlighted the trade-offs involved and the relevance of the wider context in which premedications are provided. Barriers and facilitators were identified on the acceptability of premedications more generally. CONCLUSIONS: Future clinical trials evaluating the effectiveness of premedications in children prior to general anaesthesia need to consider that premedication choice is multifactorial. The MAGIC study found that melatonin was less effective at reducing anxiety (pre-operative distress) when compared with the standard of care, midazolam. However, there remains a need for a premedication with a better side effects profile to midazolam. While children, caregivers and health professionals are open to alternatives to midazolam, this is likely to vary by subgroup and will involve trade-offs in terms of benefits. TRIAL REGISTRATION: ISCRCTN ISRCTN18296119 . Registered on 10/01/2019.