title: Fosphenytoin for seizure prevention in childhood coma in Africa: a randomized clinical trial.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  A single intramuscular injection of fosphenytoin (20 phenytoin equivalents/kg) does not prevent seizures or neurologic deficits in childhood acute nontraumatic coma.
authors.affiliation: Department of Medical Physiology, School of Health Sciences, Kenyatta University, Nairobi, Kenya; Clinical Research, Afya Research Africa, Nairobi, Kenya. Electronic address: samgwer@gmail.com.
authors.forename: Samson A
authors.initials: SA
authors.lastname: Gwer
authors.forename: Richard I
authors.initials: RI
authors.lastname: Idro
authors.forename: Gregory
authors.initials: G
authors.lastname: Fegan
authors.forename: Eddie M
authors.initials: EM
authors.lastname: Chengo
authors.forename: Ayub
authors.initials: A
authors.lastname: Mpoya
authors.forename: Esther
authors.initials: E
authors.lastname: Kivaya
authors.forename: Jane
authors.initials: J
authors.lastname: Crawley
authors.forename: Simon N
authors.initials: SN
authors.lastname: Muchohi
authors.forename: Michael N
authors.initials: MN
authors.lastname: Kihara
authors.forename: Bernhards R
authors.initials: BR
authors.lastname: Ogutu
authors.forename: Fenella J
authors.initials: FJ
authors.lastname: Kirkham
authors.forename: Charles R
authors.initials: CR
authors.lastname: Newton
mesh_terms: D000293:Adolescent; D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003128:Coma / Q000503:physiopathology*; D004311:Double-Blind Method; D004569:Electroencephalography; D005260:Female; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular; D007630:Kenya; D008297:Male; D010672:Phenytoin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010919:Placebos; D012640:Seizures / Q000503:physiopathology / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D010919:Placebos; D010672:Phenytoin; C043114:fosphenytoin
keywords: Anticonvulsants; Child; Coma; Prophylaxis; Seizure