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. 2019 Jun 18;2019(6):CD010678. doi: 10.1002/14651858.CD010678.pub3

Walker 1993.

Methods Trial design: open RCT
Trial dates: not stated
Participants Number: 54 children aged 1 to 5 years enrolled
Inclusion criteria: patients were admitted if they satisfied the strict WHO definition of cerebral malaria.
Exclusion criteria: none stated
Interventions
  • Intramuscular artemether

    • Loading dose of 3.2 mg/kg on admission...

    • ...followed by 1.6 mg/kg for 4 days.

  • Intravenous quinine

    • Loading dose of 20 mg/kg infused over 4 hours on admission...

    • ...followed by 10 mg/kg every 8 hours until patient regained consciousness...

    • ...then oral medication was continued at 10 mg/kg, every 8 hours for a total of 7 days.

Outcomes Outcomes included in the review:
  • Death

  • Coma resolution time

  • Neurological sequelae

  • Fever clearance time

  • Parasite clearance time

  • Adverse effects


Outcomes not included in the review:
  • Time to sit unaided

  • Time to drink

  • Discharge packed cell volume

  • Mortality rate

  • 28th‐day cure rate

  • Parasite recrudescence

Notes Location: University College Hospital, Ibadan, Nigeria
Transmission: unknown
Funding: World Bank/UNDP/WHO Special Fund for Research and Training in Tropical Diseases (TDR)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers used.
Allocation concealment (selection bias) Low risk "Each child was then assigned a random number from a list prepared by an independent collaborator and thus allocated at random to receive either intramuscular artemether or intravenous quinine".
Blinding (performance bias and detection bias) 
 Objective outcome: Death Low risk An open‐label trial is unlikely to bias an objective outcome like death.
Blinding (performance bias and detection bias) 
 Subjective outcomes: Others High risk "This was a randomized, open, controlled study in which no attempt was made to ‘blind’ the investigators, as the test drug and the control drug were given by 2 different routes".
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Only 1 patient excluded from fever clearance time outcome assessment because of urinary tract infection.
Selective reporting (reporting bias) Low risk No evidence of selective reporting.
Other bias Low risk No other bias identified.