Abstracts

RATIONALE: To study the effect of rectally administered diazepam (Diastat(r), Elan Pharmaceuticals) on respiration in pediatric epilepsy patients with prolonged seizures and/or seizure clusters. Prolonged seizures and/or seizure clusters can occur in epilepsy patients even with optimal antiepileptic drug therapy. Typically, rectal- or IV-administered diazepam is given to halt such seizure episodes; however, an increased risk for respiratory suppression is associated with diazepam when administered rectally or parenterally. METHODS: Retrospective review of 25 pediatric epilepsy patients diagnosed with prolonged and/or seizure cluster syndromes who received rectally administered diazepam (per product insert instructions) as treatment. The following information was obtained from chart review or verbally from patients and/or caregivers: age, weight, dose, adverse events, efficacy, and signs of respiratory suppression (color change, etc.). RESULTS: Patients ranged in age from 10 months to 21 years (mean age, 8.27 years). Mean weight was 27.95 kg (range 9.7-80 kg). The mean Diastat dose administered was 9.8 mg (range 5-20 mg); the mg/kg per dose averaged 0.4 mg/kg per dose (range 0.14-0.8 mg/kg per dose). The following adverse events were reported: fatigue-mild sedation (28%, 7/25), moderate sedation (28%, 7/25), agitation (8%, 2/25), and loss of appetite (4%, 1/25). As to efficacy, Diastat stopped seizures in 92% (23/25) of patients; of those not responding to treatment, one patient saw no effect; the other required multiple doses to control seizures. There were no signs of respiratory suppression in 96% (24/25) of the patients administered Diastat. One patient reported mild difficulty in breathing after first use but no such difficulties with further use. No respiratory assistance was needed. CONCLUSIONS: The data show that Diastat had little or no effect on respiration when administered to this population of pediatric epilepsy patients suffering from prolonged or cluster seizures. Results confirm the overall safety and efficacy of rectally administered diazepam in this treatment population.