Crawley 2000.
Methods | Randomized Placebo controlled Parallel trial |
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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 |
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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) |
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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 |