Brandts 1997.
Methods | Randomized from random numbers table. Allocation concealment unclear, unblinded. 3/50 (6%) withdrawn from the analysis after randomization. No intention‐to‐treat analysis. Ethical approval was given by the Ethics Committee of the International Foundation of the Albert Schweitzer Hospital in Lambaréné, Gabon. Informed consent was sought from patients. The study was funded by the Fortune Medical Faculty, University of Tubingen, Germany and the Osterrieichesche Gessellschaft fur Chemotherapie Austria and the AUPELF‐UREF/ARC, France. |
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Participants | 50 children with uncomplicated P. falciparum malaria. Study was conducted in Gabon, West Africa. Patients were included in the trial if they had initial asexual parasitemia between 25,000 and 200,000 parasites/μL blood, aged 2 to 7 years, had temperatures above 38 °C on admission or fever in the preceeding 24 hours, had not taken antipyretic treatment in the preceeding 8 hours and not received effective antimalarial treatment for the acute infection. Exclusion criteria: complicated malaria, Hb < 8.0 g/dL (PCV < 24%), glucose < 2.8 mmol/L, lactate > 3.5 mmol/L, schizontaemia > 50/µL, platelets < 50,000/µL, pigment‐containing neutrophils > 2%. |
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Interventions | A: mechanical antipyretic treatment (continuous electric fanning, tepid sponging and cool blankets) plus paracetamol suppositories (50 mg/kg/day at 10 to 15 mg/kg, 4 to 6 hourly); expelled suppositories replaced immediately.
B (control): mechanical antipyretic therapy (as above) without paracetamol. Similar antimalarials in both groups: intravenous quinine 15 mg/kg, 12 hourly for 4 days; then oral quinine at 15 mg/kg, 12 hourly, for 3 days. |
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Outcomes |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not specified |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Three participants reported as withdrawn from the treatment group and reasons for withdrawal given; one from the paracetamol(treatment) group and two from the mechanical antipyretics (control) group. However data on 47 patients were available for per protocol analysis |
Selective reporting (reporting bias) | Unclear risk | All pre‐specified primary and secondary outcomes were reported |
Other bias | Unclear risk | No information |