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. 2012 Sep 12;2012(9):CD002151. doi: 10.1002/14651858.CD002151.pub2

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Three participants were withdrawn (one had a convulsion after randomization and two violated the protocol).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.
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.
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).
Outcomes Primary outcomes:
Fever clearance time in hours at a threshold of 37.5 °C
Secondary outcomes:
  1. FT

  2. Area under the curve

  3. PCT

  4. Assessment of adverse effects

  5. Length of hospital stay

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 All outcomes Low risk Three participants were withdrawn and the reasons were stated.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