Abstracts

Rectal Diazepam has become the standard for pre-hospital emergency treatment of continuing or serial epileptic seizures in children. However the rectal route is inconvenient and undignified, especially in older children, particularly in non-medical and public settings. There is increasing evidence that Buccal Midazolam is safe and probably more effective, in hospital settings (1). We wished to pilot the feasibility of conducting a trial of Buccal Midazolam against Rectal Diazepam, administered and recorded by parents / guardians at home, pre-hospital. Patients already or about to be prescribed emergency treatment for home use were approached, and informed consent obtained, as approved by the Research Ethics Committee and local Research and Development departments. Parents / guardians were trained in both Rectal Diazepam and Buccal Midazolam indications for use, administration and standard data sheet completion. Patients were randomised with concealed allocation, some to get BM next then RD on the following occasion, some the other way round. Each child received each drug. Identical convenient age-related doses from 2.5 to 10 mg were used. Additional clinical data was obtained from the hospital charts. Data was entered on a data base and simple statistical analyses undertaken, including Fisher[apos]s exact test. Data on 9 children, 6 female, aged 8 months to 15 years (median 4 years) with refractory epilepsies was available. They were taking 1 to 4 regular antiepileptic drugs (AEDs) (median 2).
Seizures stopped at 1 to 30 minutes (median 9); in under 10 minutes in 9/18 episodes. Relapses within 24 hours occurred in 7/18; post-ictal sleep in 13/18 and breathing difficulties in 0/18. Parents / guardians reported drug administration easy in 13/18 episodes. There was no detectable difference between RD and BM so far for these outcomes as the numbers were, as expected, too small.
However 7/9 parents / guardians reported a preference for BM, 2/9 were unsure, none preferred RD (p[lt]0.001). Data sheets were adequately filled in. More patients are being recruited to increase the power to detect important differences in efficacy and adverse effect risk. However the parents / guardians were able to record data adequately and there was a highly significant user preference for BM over RD. (Supported by The Research and Development Department, University Hospital Trust, Queen[apos]s Medical Centre, Nottingham UK.
(1) Appleton RE, McIntyre JW, Choonara IA, Whitehouse WP, Robertson S, Norris E. Randomised controlled trial of Buccal Midazolam versus Rectal Diazepam for the emergency treatment of seizures in children, [italic]Epilepsia [/italic]2004; :Suppl.7: 186.)