Rectal diazepam gel for treatment of acute repetitive seizures. The North American Diastat Study Group

Pediatr Neurol. 1999 Apr;20(4):282-8. doi: 10.1016/s0887-8994(98)00156-8.


The purpose of these investigations was to determine from combined data the response to rectal diazepam (DZP) gel (Diastat [Athena Neurosciences, South San Francisco, CA]) in home treatment of children with episodes of acute repetitive seizures (ARS). A subset of patients aged 2-17 years were selected from two prospective placebo-controlled studies of children and adults. In both studies a prospective, double-blind, placebo-controlled design was used. The treatment groups (68 DZP; 65 placebo) did not differ significantly in age, race, seizure type or etiology, or in the median number of ARS episodes per month before study entry. DZP-treated children demonstrated a significant reduction in median seizure frequency compared with the placebo group (0.00 vs 0.25 seizures per hour, P = 0.001). Significantly more DZP-treated children remained seizure free during the observation period (40 vs 20, P = 0.001). Somnolence was the only adverse effect present significantly more often in the DZP-treated children (25.0% vs 7.7%, P = 0.0095). There were no instances of serious respiratory depression. Rectal DZP was demonstrated to be an effective and safe treatment to abort an episode of ARS in a child and, additionally, lessened the likelihood of seizure recurrence within the next 12 hours.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Acute Disease
  • Administration, Rectal
  • Adolescent
  • Anticonvulsants / administration & dosage*
  • Child
  • Child, Preschool
  • Diazepam / administration & dosage*
  • Double-Blind Method
  • Epilepsy / drug therapy*
  • Female
  • Home Nursing / methods
  • Humans
  • Male
  • Placebos
  • Prospective Studies
  • Recurrence
  • Seizures / prevention & control*


  • Anticonvulsants
  • Placebos
  • Diazepam