Objective: To compare the efficacy and safety of rectal artemether with intravenous quinine in the treatment of cerebral malaria in children.
Design: Randomised, single blind, clinical trial.
Setting: Acute care unit at Mulago Hospital, Uganda's national referral and teaching hospital in Kampala.
Participants: 103 children aged 6 months to 5 years with cerebral malaria.
Intervention: Patients were randomised to either intravenous quinine or rectal artemether for seven days.
Main outcome measures: Time to clearance of parasites and fever; time to regaining consciousness, starting oral intake, and sitting unaided; and adverse effects.
Results: The difference in parasitological and clinical outcomes between rectal artemether and intravenous quinine did not reach significance (parasite clearance time 54.2 (SD 33.6) hours v 55.0 (SD 24.3) hours, P = 0.90; fever clearance time 33.2 (SD 21.9) hours v 24.1(SD 18.9 hours, P = 0.08; time to regaining consciousness 30.1 (SD 24.1) hours v 22.67 (SD 18.5) hours, P = 0.10; time to starting oral intake 37.9 (SD 27.0) hours v 30.3 (SD 21.1) hours, P = 0.14). Mortality was higher in the quinine group than in the artemether group (10/52 v 6/51; relative risk 1.29, 95% confidence interval 0.84 to 2.01). No serious immediate adverse effects occurred.
Conclusion: Rectal artemether is effective and well tolerated and could be used as treatment for cerebral malaria.