TY - JOUR
T1 - Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy
AU - Holsti, Maija
AU - Dudley, Nanette
AU - Schunk, Jeff
AU - Adelgais, Kathleen
AU - Greenberg, Richard
AU - Olsen, Cody
AU - Healy, Aaron
AU - Firth, Sean
AU - Filloux, Francis
PY - 2010/8
Y1 - 2010/8
N2 - 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. Design: Prospective randomized study. Setting: Patients' homes and a freestanding children's hospital that serves as a referral center for 5 states. Patients: 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. Intervention: 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. Outcome Measures: The primary outcome measure was total seizure time after medication administration. Our secondary outcomemeasures 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
AB - 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. Design: Prospective randomized study. Setting: Patients' homes and a freestanding children's hospital that serves as a referral center for 5 states. Patients: 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. Intervention: 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. Outcome Measures: The primary outcome measure was total seizure time after medication administration. Our secondary outcomemeasures 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
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U2 - 10.1001/archpediatrics.2010.130
DO - 10.1001/archpediatrics.2010.130
M3 - Article
C2 - 20679166
AN - SCOPUS:77955371725
SN - 2168-6203
VL - 164
SP - 747
EP - 753
JO - A.M.A. American journal of diseases of children
JF - A.M.A. American journal of diseases of children
IS - 8
ER -