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. 2002 Apr 22;2002(2):CD002152. doi: 10.1002/14651858.CD002152

Crawley 2000.

Methods Randomized
Placebo controlled
Parallel trial
Participants Number screened: 440
Number included: 170 placebo; 170 intervention; 184 male; 156 female
Inclusion criteria: age between 9 months and 3 years; unrousable coma (non‐localizing or Blantyre score ≤ 3);
 falciparum parasitaemia
Exclusion criteria: afebrile epilepsy; significant neurodevelopmental problem; prior treatment with phenobarbitone or phenytoin in present illness; lumbar puncture revealed meningitis
Interventions Intervention: intramuscular phenobarbitone; single dose 20 mg/kg = 0.1 ml/kg
Control (placebo): 90% propylene glycol (vehicle of parenteral phenobarbitone) in similar ampoule (0.1 ml/kg)
Outcomes 1. Death
 2. Seizure
 3. Coma recovery time
 4. Neurological sequelae at discharge and at 3 months
Notes Study location: Kilifi, Kenya
Losses to follow up: 17
Intention‐to‐treat analysis only for primary outcome