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. 2014 Sep 11;2014(9):CD010678. doi: 10.1002/14651858.CD010678.pub2
Methods Trial design: Open RCT
Trial dates: Not stated
Participants Number: 160 children aged five months to 12 years enrolled
Inclusion criteria: Children were admitted to the trial if they had P. falciparum asexual parasitaemia, were comatose and parental consent was obtained.
Exclusion criteria: Children were excluded if there was evidence of a pre‐existing neurological deficit, head injury, or history of recent treatment with antimalarial drugs other than chloroquine.
Interventions 1. Intramuscular artemether (Paluther, Rhône‐Poulenc)
  • Loading dose of 3.2 mg/kg

  • Followed by 1.6 mg/kg once daily. At least three doses of artemether were given

  • Followed by sulphadoxine‐pyrimethamine if parasitaemia had cleared and the child could drink. Otherwise artemether was continued for a total of five days (four maintenance doses)


2. Intravenous quinine (Laboratoires Renaudin, Paris)
  • Loading dose of 20 mg/kg infused over four hours

  • Folowed by 10 mg/kg every eight hours with dose given over two hours. At least three doses of parenteral quinine were given, and continued until the child was able to drink and parasitaemia had cleared

  • Then a single dose of sulphadoxine‐pyrimethamine (sulphadoxine 25 mg/kg, pyrimethamine 1.25 mg/kg) given orally or intramuscularly

Outcomes Outcomes included in the review:
  1. Time to death

  2. Coma resolution

  3. Neurological sequelae

  4. Fever clearance

  5. Parasite clearance

  6. Adverse effects


Outcomes not included in the review:
  1. Mortality with respiratory distress

Notes Location: Kenya Medical Research Institute (KEMRI) Coastal Research Unit, Kilifi district hospital, Kenya.
Transmission: Unknown
Funding:
  1. KEMRI

  2. UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

  3. The Wellcome Trust

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Centrally‐coded unique trial numbers.
Allocation concealment (selection bias) Low risk Sealed envelopes prepared by the clinical monitor.
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 An open‐label trial.
Blinding unlikely as artemether and quinine were given by 2 different routes.
Incomplete outcome data (attrition bias) All outcomes Low risk 40 patients (14 from artemether arm and 26 from quinine arm) excluded. Mostly for not meeting inclusion criteria.
Selective reporting (reporting bias) Low risk No evidence of selective reporting.
Other bias Low risk No other bias identified.