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

Adam 2002.

Methods Trial design: open label RCT
 Trial dates: November 2001 to January 2002
Participants Number of participants: 41 children enrolled
 Inclusion criteria: children with severe malaria (age range not stated); cerebral malaria; repeated convulsions; severe anaemia with haemoglobin < 5g/dL; hyperparasitaemia (parasite count > 100,000 rings/µL); or combinations of these criteria.
Exclusion criteria: none stated
Interventions
  • Intramuscular artemether (Kunming Pharmaceuticals; China)

    • Loading dose of 3.2 mg/kg on day 1...

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

  • Intravenous quinine

    • Loading dose of 20 mg/kg of quinine dihydrochloride in 10 mL/kg 5% dextrose over 4 hours...

    • ...followed by 10 mg/kg of quinine dihydrochloride in 10 mL/kg 5% dextrose solution over 4 hours, every 8 hours for at least 72 hours...

    • ...followed by oral quinine (for 7 days as soon as patient could tolerate).

Outcomes Outcomes included in the review:
  • Death

  • Coma resolution time

  • Parasite clearance time

  • Fever clearance time

  • Episodes of hypoglycaemia


Outcomes not included in the review:
  • Gametocyte carriage

  • Recrudescence

Notes Location: Outpatient clinic in New Halfa, Eastern Sudan
 Transmission: "meso‐endemic"
Funding: none stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Each child was randomized". No further details provided.
Allocation concealment (selection bias) Low risk "Envelopes containing the assigned treatment were opened sequentially at the time when each patient was recruited to the study".
Blinding (performance bias and detection bias) 
 Objective outcome: Death Low risk Described as open‐label. However, lack of blinding is unlikely to bias an objective outcome like death.
Blinding (performance bias and detection bias) 
 Subjective outcomes: Others High risk An open‐label trial.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No losses to follow‐up were reported.
Selective reporting (reporting bias) Low risk No evidence of selective reporting.
Other bias Low risk No other bias identified.