Aguwa 2010 NGA

Methods	Trial design: RCT Trial dates: July to October 2007
Participants	Number of participants: 90 children enrolled Inclusion criteria: Children between six months and 12 years of age presenting with fever (> 37.5°C ) and P. falciparum infection with one or more general danger signs of severe or complicated malaria based on the WHO criteria for severe malaria Exclusion criteria: Serious concomitant illness, for example, sickle cell anaemia, HIV, tuberculosis and other chronic diseases, severe malnutrition, known hypersensitivity to one of the trial drugs.
Interventions	1. Intramuscular artemether (Paluther; May and Baker) Loading dose of 3.2 mg/kg on admission Followed by 1.6 mg/kg once daily for two days 2.Intravenous or intramuscular quinine (Quinimax; Sanofi) Loading dose 20 mg salt/kg body weight on admission Followed by 10 mg/kg every eight hours; the infusion rate did not exceed 5 mg salt/kg per hour
Outcomes	Outcomes included in the review: Death Proportion of patients recovered from coma on day 3 Proportion of patients discharged by day 7 Proportion of patients with fever clearance on day 3 and day 14 Proportion of patients with parasite clearance on day 3 and day 14 Outcomes not included in the review: Hospital bed‐days
Notes	Location: Federal Medical Centre, Birnin Kudu, Jigawa State of Nigeria Transmission: Stable perennial transmission Funding: None stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	"Patients were assigned to receive quinine if the last digit of their hospital identification number was odd and to receive artemether if the last digit of their hospital identification number was even or zero".
Allocation concealment (selection bias)	High risk	Trial authors did not describe any methods of allocation concealment, and this would not be possible using this randomization method.
Blinding (performance bias and detection bias) Objective outcome: Death	Low risk	No blinding was described. However, lack of blinding is unlikely to bias an objective outcome like death.
Blinding (performance bias and detection bias) Subjective outcomes: Others	High risk	No blinding is described, and blinding would not be feasible.
Incomplete outcome data (attrition bias) All outcomes	High risk	Losses to follow‐up at day 14 were > 10% in both trial arms.
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting.
Other bias	Low risk	No other bias identified.