Abstracts

Rectal diazepam and, more recently, buccal midazolam have been used in the emergency or rescue treatment of acute seizures in children. There is uncertainty as to which is the most effective and safest. This purpose of this study was to compare the safety and efficacy of buccal midazolam (BM) and rectal diazepam (RD) in the emergency room treatment of acute seizures. A multi-centre, randomised controlled trial was undertaken comparing buccal midazolam with rectal diazepam for the emergency room treatment of children aged six months and over presenting to hospital in a tonic-clonic seizure and with no intravenous access. The dose of midazolam and diazepam varied according to age from 2.5 to 10 mg. The primary end point, therapeutic success, was the cessation of seizures within 10 minutes and for at least one hour, without respiratory depression requiring medical intervention. The study received ethical approval from the Regional and Local Ethics Committees of the participating centres. Written consent was obtained. Weekly blocks of treatment to either BM or RD were randomly selected for each of the participating centres. Consent was obtained in 219 (male, 56.2%) separate episodes involving 177 (male, 55.4%) patients, median age 3 years (interquartile range, 1 to 5 years). Therapeutic success was achieved in 61 (56%) episodes treated with BM (n=109) and 30 (27.3%) episodes treatd with RD (N=110). Buccal midazolam was more likely to stop the seizures within 10 minutes (65% vs 41%; p[lt]0.001). The number of patients given intravenous lorazepam for continuing seizure activity after BM was 36 (33%) compared with 63 (57.3%) after RD (p[lt]0.001). Respiratory depression was recorded in 5 (4.6%) and 7 (6.4%) of the BM and RD-treated groups respectively. In logistic regression analysis where age, known diagnosis of epilepsy, use of antiepileptic drugs and duration of seizure prior to treatment were adjusted for, BM was more effective than RD (p[lt]0.001; Odds Ratio, 3.7; Confidence Intervals, 2.1-6.8). Buccal midazolam was more effective than rectal diazepam for children presenting to the hospital emergency room with acute tonic-clonic seizures and was not associated with an increased incidence of respiratory depression. The nursing staff in the emergency rooms found the buccal midazolam easier and more acceptable to administer than the rectal diazepam; this view was also shared by most parents. The results of this randomised controlled trial will now be used to change the practice of the emergency or rescue treatment of acute tonic-clonic seizures in children in both hospital and out-of-hospital situations. (Supported by [apos]SEARCH[apos])