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. 2014 Sep 11;2014(9):CD010678. doi: 10.1002/14651858.CD010678.pub2
Methods Trial design: Open RCT
Trial dates: June 1993 to February 1994 and June 1994 to December 1994
Participants Number of participants: 67 children aged three months to 15 years enrolled
Inclusion criteria: Fever (core temperature ≥ 38 °C), positive blood smear for P. falciparum with ≥ 0.1% of parasitized erythrocytes, one major criterion or two minor criteria for severe malaria cases (WHO criteria) and parental consent
Exclusion criteria: Patients with infection who had been treated within 24 hours with quinine or intramuscular injection was not eligible.
Interventions 1. Intramuscular artemether (Paluther)
  • Loading dose of 3.2 mg/kg on admission (two times)

  • Followed by 1.6 mg/kg once daily for four days


2. Intravenous quinine
  • Loading dose of 20 mg/kg on admission

  • Followed by 10 mg/kg every eight hours until oral drug administration was possible (10 mg/kg every eight hours)

Outcomes Outcomes included in the review:
  1. Death

  2. Coma resolution time

  3. Fever clearance

  4. Parasite clearance

  5. Adverse events


Outcomes not included in the review:
  1. Recrudescence

Notes Location: Gabriel Touré's Hospital, Mali
Transmission: Unknown
Funding: Rhône‐Poulenc Rorer Doma (France)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Central randomization by clinical monitor.
Allocation concealment (selection bias) Low risk Opaque envelopes used to conceal allocation.
Blinding (performance bias and detection bias) Objective outcome: Death Low risk An open‐label trial is unlikely to bias an objective outcome like death.
No blinding is described, and blinding would not be feasible.
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 reported.
Selective reporting (reporting bias) Low risk No evidence of selective reporting.
Other bias Low risk No other bias identified.