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Rectal artemether versus intravenous quinine for the treatment of cerebral malaria in children in Uganda: randomised clinical trial

BMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7487.334 (Published 10 February 2005) Cite this as: BMJ 2005;330:334
  1. Jane Ruth Aceng, registrar1,
  2. Justus S Byarugaba, senior consultant1,
  3. James K Tumwine, associate professor (jtumwine{at}imul.com)1
  1. 1 Department of Paediatrics and Child Health, Makerere Medical School, PO Box 7072, Kampala, Uganda
  1. Correspondence to: J K Tumwine
  • Accepted 17 December 2004

Abstract

Abstract Objective To compare the efficacy and safety of rectal artemether with intravenous quinine in the treatment of cerebral malaria in children.

Design Randomised, single blind, clinical trial.

Setting Acute care unit at Mulago Hospital, Uganda's national referral and teaching hospital in Kampala.

Participants 103 children aged 6 months to 5 years with cerebral malaria.

Intervention Patients were randomised to either intravenous quinine or rectal artemether for seven days.

Main outcome measures Time to clearance of parasites and fever; time to regaining consciousness, starting oral intake, and sitting unaided; and adverse effects.

Results The difference in parasitological and clinical outcomes between rectal artemether and intravenous quinine did not reach significance (parasite clearance time 54.2 (SD 33.6) hours v 55.0 (SD 24.3) hours, P = 0.90; fever clearance time 33.2 (SD 21.9) hours v 24.1(SD 18.9 hours, P = 0.08; time to regaining consciousness 30.1 (SD 24.1) hours v 22.67 (SD 18.5) hours, P = 0.10; time to starting oral intake 37.9 (SD 27.0) hours v 30.3 (SD 21.1) hours, P = 0.14). Mortality was higher in the quinine group than in the artemether group (10/52 v 6/51; relative risk 1.29, 95% confidence interval 0.84 to 2.01). No serious immediate adverse effects occurred.

Conclusion Rectal artemether is effective and well tolerated and could be used as treatment for cerebral malaria.

Footnotes

  • Contributors JRA, JSB, and JKT designed and coordinated the study. JRA supervised enrolment and follow up of patients. JRA and JKT analysed and interpreted the data and wrote the manuscript. JSB helped in interpreting the data and revising the manuscript. JKT is guarantor.

  • Funding World Health Organization, Uganda country office; Uganda Malaria surveillance Project; Regional Center for Quality of Health Care; Ministry of Health, Uganda; and the Nuffield Foundation, United Kingdom, provided financial support. Dafra Pharma (Belgium) supplied the suppogels (rectal artemether and rectal placebos). Rene Pharmaceuticals (Uganda) provided the oral placebos.

  • Competing interests None declared

  • Ethical approval Makerere Faculty of Medicine Ethics and Research Committee and Uganda National Council for Science and Technology.

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