Methods | Trial design: Open RCT Trial dates: Not stated |
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Participants | Number: 160 children aged five months to 12 years enrolled Inclusion criteria: Children were admitted to the trial if they had P. falciparum asexual parasitaemia, were comatose and parental consent was obtained. Exclusion criteria: Children were excluded if there was evidence of a pre‐existing neurological deficit, head injury, or history of recent treatment with antimalarial drugs other than chloroquine. |
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Interventions | 1. Intramuscular artemether (Paluther, Rhône‐Poulenc)
2. Intravenous quinine (Laboratoires Renaudin, Paris)
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Outcomes | Outcomes included in the review:
Outcomes not included in the review:
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Notes | Location: Kenya Medical Research Institute (KEMRI) Coastal Research Unit, Kilifi district hospital, Kenya. Transmission: Unknown Funding:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Centrally‐coded unique trial numbers. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes prepared by the clinical monitor. |
Blinding (performance bias and detection bias) Objective outcome: Death | Low risk | An open‐label trial is unlikely to bias an objective outcome like death. |
Blinding (performance bias and detection bias) Subjective outcomes: Others | High risk | An open‐label trial. Blinding unlikely as artemether and quinine were given by 2 different routes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 40 patients (14 from artemether arm and 26 from quinine arm) excluded. Mostly for not meeting inclusion criteria. |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. |
Other bias | Low risk | No other bias identified. |