Lorazepam versus diazepam-phenytoin combination in the treatment of convulsive status epilepticus in children: a randomized controlled trial.
BACKGROUND
Convulsive status epilepticus demands urgent and appropriate management with anticonvulsants. Intravenous diazepam is an established drug in the management of convulsive status epilepticus in adults as well as in children. The efficacy of intravenous lorazepam has not been well established in children.


OBJECTIVE
To determine whether intravenous lorazepam is as efficacious as diazepam-phenytoin combination in the treatment of convulsive status epilepticus in children.


METHODS
Randomized controlled trial.


METHODS
A total of 178 children were enrolled in the study; 90 in the lorazepam group and 88 in the diazepam-phenytoin combination group. Enrolled subjects were between 1 and 12 years with a clinical diagnosis of convulsive status epilepticus, presenting in pediatric emergency of a tertiary care hospital. They were randomized to receive either intravenous lorazepam (0.1 mg/kg) or intravenous diazepam (0.2 mg/kg)-phenytoin (18 mg/kg) combination at admission and were followed up for subsequent 18 h.


RESULTS
The overall success rate of therapy was 100% in both the groups. There was no statistically significant difference in the two groups (lorazepam versus diazepam-phenytoin combination) in the median time taken to stop the seizure [20s in both groups], the number of subjects requiring more than one dose of the study drug to stop the presenting seizure [lorazepam 6(6.7%) versus diazepam-phenytoin combination: 14 (15.9%); adjusted RR (95% CI)=0.377 (0.377, 1.046); P=0.061] and the number (%) of patients having respiratory depression [lorazepam 4(4.4%) versus diazepam-phenytoin combination 5 (5.6%)]. None of the patients in the two groups required additional anticonvulsant drug to stop the presenting seizure. No patient required mechanical ventilation and none of the patients in the two groups required cross-over to the alternative regimen.


CONCLUSIONS
Lorazepam is as efficacious and safe as diazepam-phenytoin combination. We recommend use of lorazepam as a single drug to replace the two drug combination of diazepam-phenytoin combination to control the initial seizure in pediatric convulsive status epilepticus.
Sreenath
T G
TG
Department of Pediatrics, University College of Medical Sciences and Guru Tegh Bahadur Hospital, Delhi 110095, India.
Gupta
Piyush
P
Sharma
K K
KK
Krishnamurthy
Sriram
S
D000465:Algorithms; D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003975:Diazepam / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004569:Electroencephalography; D005260:Female; D018757:GABA Modulators / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D008140:Lorazepam / Q000627:therapeutic use*; D008297:Male; D010672:Phenytoin / Q000627:therapeutic use*; D013226:Status Epilepticus / Q000175:diagnosis / Q000188:drug therapy*
D000927:Anticonvulsants; D018757:GABA Modulators; D010672:Phenytoin; D008140:Lorazepam; D003975:Diazepam