Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy.
OBJECTIVE
To compare intranasal midazolam, using a Mucosal Atomization Device (IN-MMAD), with rectal diazepam (RD) for the home treatment of seizures in children with epilepsy.


METHODS
Prospective randomized study.


METHODS
Patients' homes and a freestanding children's hospital that serves as a referral center for 5 states.


METHODS
A total of 358 pediatric patients who visited a pediatric neurology clinic from July 2006 through September 2008 and were prescribed a home rescue medication for their next seizure.


METHODS
Caretakers were randomized to use either 0.2 mg/kg of IN-MMAD (maximum, 10 mg) or 0.3 to 0.5 mg/kg of RD (maximum, 20 mg) at home for their child's next seizure if it lasted more than 5 minutes.


METHODS
The primary outcome measure was total seizure time after medication administration. Our secondary outcome measures were total seizure time, time to medication administration, respiratory complications, emergency medical service support, emergency department visits, hospitalizations, and caretakers' ease of administration and satisfaction with the medication.


RESULTS
A total of 92 caretakers gave the study medication during a child's seizure (50 IN-MMAD, 42 RD). The median time from medication administration to seizure cessation for IN-MMAD was 1.3 minutes less than for RD (95% confidence interval, 0.0-3.5 minutes; P=.09). The median time to medication administration was 5.0 minutes for each group. No differences in complications were found between treatment groups. Caretakers were more satisfied with IN-MMAD and report that it was easier to give than RD.


CONCLUSIONS
There was no detectable difference in efficacy between IN-MMAD and RD as a rescue medication for terminating seizures at home in pediatric patients with epilepsy. Ease of administration and overall satisfaction was higher with IN-MMAD compared with RD. Trial Registration clinicaltrials.gov Identifier: NCT00326612.
Holsti
Maija
M
Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108, USA. maija.holsti@hsc.utah.edu
Dudley
Nanette
N
Schunk
Jeff
J
Adelgais
Kathleen
K
Greenberg
Richard
R
Olsen
Cody
C
Healy
Aaron
A
Firth
Sean
S
Filloux
Francis
F
D000208:Acute Disease; D000281:Administration, Intranasal; D000285:Administration, Rectal; D000927:Anticonvulsants / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D003975:Diazepam / Q000008:administration & dosage*; D004311:Double-Blind Method; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006699:Home Care Services; D006801:Humans; D008297:Male; D008874:Midazolam / Q000008:administration & dosage*; D009330:Nebulizers and Vaporizers; D011446:Prospective Studies
D000927:Anticonvulsants; D003975:Diazepam; D008874:Midazolam