Matsegui 2008.
Methods | Randomized double blind placebo trial. Method of randomization was computer generated. Allocation was concealed using sealed envelopes. Per protocol analysis was done for primary outcome while intention to treat analysis was done for adverse effects. Data on all patients was available for intention‐to‐treat analysis. Three participants were withdrawn (one had a convulsion after randomization and two violated the protocol). The study was ethically approved by the Ethics Committee, International Foundation of Albert Schweitzer Hospital (Lambare´ne´, Gabon). Some form of support was obtained from the University of Tubingen, Germany. |
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Participants | 50 children with uncomplicated P. falciparum (parasite density: 20,000 to 200,000/µL). Aged 2 to 7 years. Gabon, West Africa. Exclusion criteria: complicated malaria, Hb < 7.0 g/dL (PCV < 20%), schizontaemia > 50/µL, platelets < 50,000/µL, white cell count > 16,000/µL, platelet count< 40,000/µL. |
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Interventions | Group A (treatment): infusion of 250 ml of 5% glucose with 12 mg/kg of quinine dihydrochloride every 12 hours for 72 hours + single dose of SP + mechanical treatment (continous fanning and cooling blanket) + ibuprofen syrup (nurofen 7 mg/kg every eight hours) until fever and parasite clearance achieved. Group B (placebo): infusion of 250 ml of 5% glucose with 12mg/kg of quinine dihydrochloride every 12 hours for 72 hours + single dose of SP + mechanical treatment (continous fanning and cooling blanket). |
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Outcomes |
Primary outcomes: Fever clearance time in hours at a threshold of 37.5 °C Secondary outcomes:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double (participants and study personel) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Three participants were withdrawn and the reasons were stated. |
Selective reporting (reporting bias) | Low risk | All pre‐specified primary and secondary outcomes were reported. |
Other bias | Unclear risk | No information |