Fosphenytoin for seizure prevention in childhood coma in Africa: a randomized
clinical trial.
Author(s): Gwer SA(1), Idro RI, Fegan G, Chengo EM, Mpoya A, Kivaya E, Crawley J, Muchohi
SN, Kihara MN, Ogutu BR, Kirkham FJ, Newton CR.
Affiliation(s): Author information:
(1)Department of Medical Physiology, School of Health Sciences, Kenyatta University,
Nairobi, Kenya; Clinical Research, Afya Research Africa, Nairobi, Kenya.
Electronic address: samgwer@gmail.com.
Publication date & source: 2013, J Crit Care. , 28(6):1086-92
PURPOSE: We conducted a double-blind trial to determine whether a single
intramuscular injection of fosphenytoin prevents seizures and neurologic sequelae
in children with acute coma.
METHODS: We conducted this study at Kilifi District Hospital in coastal Kenya and
Kondele Children's Hospital in western Kenya. We recruited children (age, 9
months to 13 years) with acute nontraumatic coma. We administered fosphenytoin
(20 phenytoin equivalents/kg) or placebo and examined the prevalence and
frequency of clinical seizures and occurrence of neurocognitive sequelae.
RESULTS: We recruited 173 children (median age, 2.6 [interquartile range,
1.7-3.7] years) into the study; 110 had cerebral malaria, 8 had bacterial
meningitis, and 55 had encephalopathies of unknown etiology. Eighty-five children
received fosphenytoin and 88 received placebo. Thirty-three (38%) children who
received fosphenytoin had at least 1 seizure compared with 32 (36%) who received
placebo (P = .733). Eighteen (21%) and 15 (17%) children died in the fosphenytoin
and placebo arms, respectively (P = .489). At 3 months after discharge, 6 (10%)
children in the fosphenytoin arm had neurologic sequelae compared with 6 (10%) in
the placebo arm (P = .952).
CONCLUSION: A single intramuscular injection of fosphenytoin (20 phenytoin
equivalents/kg) does not prevent seizures or neurologic deficits in childhood
acute nontraumatic coma.
|