Methods | Trial design: Open RCT Trial dates: Not stated |
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Participants | Number: 54 children aged one to five years enrolled Inclusion criteria: Patients were admitted if they satisfied the strict WHO definition of cerebral malaria. Exclusion criteria: None stated |
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Interventions | 1. Intramuscular artemether
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: 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 | Random numbers used. |
Allocation concealment (selection bias) | Low risk | "Each child was then assigned a random number from a list prepared by an independent collaborator and thus allocated at random to receive either intramuscular artemether or intravenous quinine". |
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 | "This was a randomized, open, controlled study in which no attempt was made to ‘blind’ the investigators, as the test drug and the control drug were given by 2 different routes". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only one patient excluded from fever clearance time outcome assessment because of urinary tract infection. |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. |
Other bias | Low risk | No other bias identified. |