| Methods |
Randomized controlled trial |
| Participants |
Children aged between 3 and 190 months, weighing at least 7.5kg, with positive thick film for malaria, monoinfection with P. falciparum and 20 or more parasites per 2000 leukocytes. Patients were excluded if they had convulsions, severe vomitting, severe anemia, severe concurrent infection or needed hospital care for any other reason. |
| Interventions |
Paracetamol at 50 mg/kg body weight per day for three days. |
| Outcomes |
Early treatment failure, late parasitological failure, adequate clinical and parasitologial response (PCR adjusted), incidence of convulsions. |
| Notes |
Ethical approval was obtained from the Direccao de Higiene e Epidemiologia, Ministerio da Saude Publica in Guinea Bissau. Study was funded by the Department of Infectious Diseases, Malarsjukhuset, Eskildstuna. Also the drugs were donated by GSK (paracetamol/placebo) and Recip (Chloroquine). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated explicitly |
| Allocation concealment (selection bias) |
Low risk |
Randomization numbers were kept separately at the Department of Pediatrics in Kolding, Denmark |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Not stated explicitly who was blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
An intention‐to‐treat analysis was performed and also authors attempted to account for all missing data by employing a best case, worst case scenario |
| Selective reporting (reporting bias) |
Low risk |
Although we do not have the protocol, we have no reason to believe the authors selectively reported the study outcomes. |
| Other bias |
Unclear risk |
No information provided on this. |
