Methods | Trial design: Open label RCT Trial dates: Not stated |
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Participants | Number of participants: 103 children aged 11 months to five years enrolled Inclusion criteria: Children aged six months to 5 years satisfying the WHO criteria for cerebral malaria, viz. unrousable coma lasting more than 30 minutes (with or without convulsions) with the presence of peripheral P. falciparum parasitaemia were included in the trial. Exclusion criteria: None stated |
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Interventions | 1. Intramuscular artemether
2. Intravenous quinine (Lemquine®)
Loading dose quinine was omitted in patients with a positive history of quinine or mefloquine ingestion in the preceding 24 hours before hospital presentation. |
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Outcomes | Outcomes included in the review:
Outcomes not included in the review:
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Notes | Location: Emergency Paediatric ward, University College Hospital, Ibadan, Nigeria Transmission: Unknown Funding: World Bank/UNDP/WHO special fund for Research and Training in Tropical Diseases (TDR) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated allocation. |
Allocation concealment (selection bias) | Unclear risk | Methods not described by trial authors. |
Blinding (performance bias and detection bias) Objective outcome: Death | Low risk | Unlikely to be biased whether blinding was done or not. |
Blinding (performance bias and detection bias) Subjective outcomes: Others | High risk | No information of blinding reported by authors. Blinding unlikely as artemether and quinine were given by 2 different routes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up recorded. |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. |
Other bias | Low risk | No other bias identified. |