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. 2019 Jun 18;2019(6):CD010678. doi: 10.1002/14651858.CD010678.pub3

Osonuga 2009.

Methods Trial design: RCT
Trial dates: not stated
Participants Number: 32 children aged 1 to 12 years enrolled
Inclusion criteria: children aged 1 to 12 years, with fever (temperature > 37.5 °C), presence of convulsion, vomiting, hypoglycaemia, anaemia and headache. Informed consent obtained from the parents and guardians. Assurance that patients will be resident within catchments of trial for follow‐up. Absence of concomitant illness such as bronchopneumonia, typhoid, meningitis, urinary tract infection.
Exclusion criteria: history of blood transfusion in the last 2 months, presence of concomitant illness, history of previous allergy to quinine and artemether.
Interventions
  • Intramuscular artemether (Rhône‐Poulence, Rorer France)

    • Loading dose of 1.6 mg/kg twice on day 0...

    • ...followed by 1.6 mg/kg once daily for the next 4 days

  • Intravenous quinine (Evans)

    • Loading dose of 10 mg/kg infused over 4 hours...

    • ...followed by 10 mg/kg given at 8‐hour intervals and oral quinine (10 mg/kg body weight, 8‐hour intervals) as soon as the patient's condition allowed.


Treatment with quinine was for a total of 7 days.
Outcomes Outcomes included in the review:
  • Coma resolution time

  • Fever clearance time

  • Parasite clearance time


Outcomes not included in the review: none
Notes Location: Overcomers Specialist Clinic Ileshan and General Hospital Ikenne, Nigeria
Transmission: unknown
Funding: none stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "The children were randomly allocated into 2 treatment groups; treatment Q and A for quinine and artemether respectively".
Allocation concealment (selection bias) Unclear risk No information on allocation concealment provided by trial authors.
Blinding (performance bias and detection bias) 
 Objective outcome: Death Low risk Unlikely to be biased whether blinding was done or not.
Blinding (performance bias and detection bias) 
 Subjective outcomes: Others High risk No information of blinding reported by authors.
Blinding unlikely as artemether and quinine were given by 2 different routes.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Attrition about 6% and not likely to affect outcomes.
Selective reporting (reporting bias) Low risk No evidence of selective reporting. Authors have published 3 outcomes in 3 different publications from the same trial.
Other bias Low risk No other bias identified.