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

Olumese 1999.

Methods Trial design: open label RCT
Trial dates: not stated
Participants Number of participants: 103 children aged 11 months to 5 years enrolled
Inclusion criteria: Children aged 6 months to 5 years satisfying the WHO criteria for cerebral malaria, viz. unrousable coma lasting more than 30 minutes (with or without convulsions) with the presence of peripheral P falciparum parasitaemia were included in the trial.
Exclusion criteria: none stated
Interventions
  • Intramuscular artemether

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

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

  • Intravenous quinine (Lemquine®)

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

    • ...followed by 10 mg/kg infused over 2 hours given every 8 hours until the patient is conscious and oral quinine continued at 10 mg/kg orally every 8 hours to complete a total of 21 doses or 7 days


Loading dose quinine was omitted in patients with a positive history of quinine or mefloquine ingestion in the preceding 24 hours before hospital presentation.
Outcomes Outcomes included in the review:
  • Death

  • Parasite clearance time

  • Fever clearance time

  • Survival and neurological symptoms

  • Coma recovery time

  • Neurological deficits

  • Blood transfusions


Outcomes not included in the review:
  • Time to full ambulation

Notes Location: Emergency Paediatric ward, 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 Computer‐generated allocation.
Allocation concealment (selection bias) Unclear risk Methods not described by trial authors.
Blinding (performance bias and detection bias) 
 Objective outcome: Death Low risk Unlikely to be biased whether blinding was done or not.
Blinding (performance bias and detection bias) 
 Subjective outcomes: Others High risk No information of blinding reported by authors.
Blinding unlikely as artemether and quinine were given by 2 different routes.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No losses to follow‐up recorded.
Selective reporting (reporting bias) Low risk No evidence of selective reporting.
Other bias Low risk No other bias identified.