Study design and participants
learning disabilities, throat, anxiety
BLIND
This multicentre, parallel-group, double blind, individual participant-randomised trial took place across 20 UK NHS Hospital Trusts. Delegated research staff identified, assented, and randomised paediatric participants identified as anxious on the day of surgery. Trial information was given via age-specific patient information sheets and short video animation. Eligible participants were anxious children aged 3–14 yr, scheduled for elective dental, ear, nose, and throat (ENT), ophthalmology, gastroenterology, radiology, plastic, orthopaedic, urology, or general surgery under general anaesthetic. As a pragmatic trial, preoperative anxiety as eligibility for inclusion was left to clinical judgement of the responsible anaesthetist, as per local standard of care. This reflects normal practice in the UK. There is no clinically validated objective measure or universal guidance on the selection of children for premedication in the UK, where the decision is based on anaesthetists' judgement. Therefore, prescribing practice can vary from clinician to clinician. Decision-making for premedication is undertaken at preassessment clinics, on the morning of surgery when the anaesthetist assesses the child, or both. Participants were American Society of Anesthesiologists (ASA) physical status 1 or 2 and required written caregiver’s consent for entry into the trial.Exclusion criteria were: children deemed non-anxious by the responsible anaesthetist; surgery requiring inpatient admission (non-day-case); premedication required for reasons other than anxiety; current prescription of melatonin, midazolam, or drug that contraindicated the co-prescription of either trial medication; presence of severe learning disabilities rendering verbal and written communication difficult; ASA physical status 3, 4, or 5; and caregiver not consenting to participation in the trial. This population was similar to that of trials which assessed the efficacy of midazolam.