The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia.

BACKGROUND: Child anxiety before general anaesthesia and surgery is common. Midazolam is a commonly used premedication to address this. Melatonin is an alternative anxiolytic, however trials evaluating its efficacy in children have delivered conflicting results. METHODS: This multicentre, double-blind randomised trial was performed in 20 UK NHS Trusts. A sample size of 624 was required to declare noninferiority of melatonin. Anxious children, awaiting day case elective surgery under general anaesthesia, were randomly assigned 1:1 to midazolam or melatonin premedication (0.5 mg kg-1, maximum 20 mg) 30 min before transfer to the operating room. The primary outcome was the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). Secondary outcomes included safety. Results are presented as n (%) and adjusted mean differences with 95% confidence intervals. RESULTS: The trial was stopped prematurely (n=110; 55 per group) because of recruitment futility. Participants had a median age of 7 (6-10) yr, and 57 (52%) were female. Intention-to-treat and per-protocol modified Yale Preoperative Anxiety Scale-Short Form analyses showed adjusted mean differences of 13.1 (3.7-22.4) and 12.9 (3.1-22.6), respectively, in favour of midazolam. The upper 95% confidence interval limits exceeded the predefined margin of 4.3 in both cases, whereas the lower 95% confidence interval excluded zero, indicating that melatonin was inferior to midazolam, with a difference considered to be clinically relevant. No serious adverse events were seen in either arm. CONCLUSION: Melatonin was less effective than midazolam at reducing preoperative anxiety in children, although the early termination of the trial increases the likelihood of bias. CLINICAL TRIAL REGISTRATION: ISRCTN registry: ISRCTN18296119.

Does day case pediatric tonsillectomy increase postoperative pain compared to overnight stay pediatric tonsillectomy? A prospective comparative audit.

BACKGROUND: Clinical and financial pressures in the United Kingdom's National Health Service have been a stimulus for change from overnight stay to day case surgery for many procedures, including pediatric tonsillectomy. There are no prospective studies to assess whether such a change in practice alters children's experiences of pain and perioperative morbidity. Therefore, we undertook a prospective audit to measure these adverse outcomes during this change of practice in our unit. METHODS: Sixty children aged between 3 and 15 years who required tonsillectomy were recruited to this prospective comparative audit. Children received treatment on either an overnight stay (n = 28) or day case (n = 32) basis following a strict perioperative care pathway. The primary endpoints were the pain scores reported using a visual analogue scale, and secondary endpoints were vomiting, consultation with healthcare providers, readmission and patient satisfaction. Outcome data were collected from parents at 24 h and 7 days. RESULTS: There was a small, but significant, risk of greater baseline pain scores in the day case surgery group during the first 24 h. However, there was no difference in the worst pain experienced during the first 24 h, or any pain experienced at 7 days. There was no difference in any of the secondary outcome measures between the groups. CONCLUSIONS: Change in practice from overnight stay to day case surgery for pediatric tonsillectomy requires careful consideration of how to extend effective analgesia for this painful procedure into the home.