Denis R. Katundu MD1, Peter S. Shija MD MMED1, Baltazari Nyombi, PhD3, Hadija Semvua, PhD4, Fieke K. Oussoren, BSc2, Niels van Heerbeek, MD PhD1,2
Publication year: 


  Adenotonsillectomy is the most frequently performed operation in children worldwide. For decades prophylactic antibiotics have been prescribed to limit postoperative complications. In a Cochrane review the effect of this antibiotic use has been refuted. However, all reviewed studied were done in developed countries. In Tanzania, like many other developing countries with limited resources and a high burden of infectious diseases, postoperative antibiotic prescription is still very common to decrease the supposed higher postoperative morbidity. However, as a consequence of this widespread use of postoperative antibiotics cross-resistance and risk of allergic side effects rise. Well designed randomised controlled trials are needed to limit unnecessary antibiotic prescription and secondary antibiotic resistance. Aim: The aim of this study is to analyse the prophylactic role of postoperative antibiotic on the morbidity following adenotonsillectomy in children in Tanzania.Design: A double blinded randomised placebo controlled trial set in northern Tanzania. Participating centres are the department of otolaryngology at Kilimanjaro Christian Medical Centre (KCMC) in Moshi and the department of paediatric surgery at the Arusha Lutheran Medical Centre (ALMC) in Arusha. Methods: Around 270 children aged 2 to 14 years, all scheduled for elective (adeno)tonsillectomy, will be included and assigned to receive either a standard regimen of 5 days antibiotic prophylaxis or placebo after surgery. The primary outcomes are postoperative haemorrhage, raised temperature, pain and consequent need for analgesics. Secondary outcomes are the time until normal diet is resumed, the time until normal activities are resumed and the occurrence of adverse events. Finally, microbial recolonization of the tonsillar beds is analyzed. Discussion: This study will enhance increase of proper antimicrobial prescription in Tanzanian institutions as well as other resource-limited countries where prescription of antibiotics is still very common. In addition, it might augment current knowledge about surface and core tonsillar micro-organisms and sensitivity patterns.Trial registered to Pan African Clinical Trials Registry (PACTR) with Trial registration number PACTR201905466349317, registered Retrospectively on 15 May 2019 with trial registry record



 This study is a two centre, double-blind, randomized controlled trial. Patients will be randomly allocated to receive either no antibiotics after surgery or a standard regimen of 5 days prophylaxis amoxicillin. Study settingParticipating centres are the department of otolaryngology at Kilimanjaro Christian Medical Centre (KCMC) in Moshi and the department of paediatric surgery at the Arusha Lutheran Medical Centre (ALMC) in Arusha, being the only settings with established Ear, Nose and Throat (ENT) services in northern Tanzania.Study populationAll Children from 2 to 14 years of age who will undergo an elective (adeno)tonsillectomy will be approached. Elective surgery is indicated in case of recurrent chronic tonsillitis, as defined by 5 or more episodes of tonsillitis yearly for at least 2 consecutive years, or in case of obstructive sleep apnoea due to adenotonsillar hypertrophy with inadequate response to pharmacotherapy. Inclusion will be done after written informed consent. Inclusion of patients started January 2019..