Methods | Trial design: Open RCT Trial dates: June 1993 to February 1994 and June 1994 to December 1994 |
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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. |
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Interventions | 1. Intramuscular artemether (Paluther)
2. Intravenous quinine
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Outcomes | Outcomes included in the review:
Outcomes not included in the review:
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Notes | Location: Gabriel Touré's Hospital, Mali Transmission: Unknown Funding: Rhône‐Poulenc Rorer Doma (France) |
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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. |