{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:27:04Z","timestamp":1772166424038,"version":"3.50.1"},"reference-count":10,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,12,1]],"date-time":"2019-12-01T00:00:00Z","timestamp":1575158400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,12,9]],"date-time":"2019-12-09T00:00:00Z","timestamp":1575849600000},"content-version":"vor","delay-in-days":8,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Radboud University Medical Centre Revolving Research Fund","award":["20180578252"],"award-info":[{"award-number":["20180578252"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Adenotonsillectomy is the most frequently performed operation in children worldwide. For decades, prophylactic antibiotics have been prescribed to limit postoperative complications. The effect of this antibiotic use has been refuted in a Cochrane Review. However, all reviewed studies were carried out 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 randomized controlled trials are needed to limit unnecessary antibiotic prescription and secondary antibiotic resistance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>The aim of this study is to analyse the prophylactic role of postoperative antibiotics on morbidity following adenotonsillectomy in children in Tanzania.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>The double-blinded, randomized, placebo-controlled trial was set in northern Tanzania. Participating centres are the Department of Otolaryngology at Kilimanjaro Christian Medical Centre in Moshi and the Department of Paediatric Surgery at the Arusha Lutheran Medical Centre in Arusha.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Around 270 children aged 2\u201314\u2009years, all scheduled for elective (adeno)tonsillectomy, will be included and assigned to receive either a standard regimen of 5\u2009days of antibiotic prophylaxis or placebo after surgery. The primary outcomes are postoperative haemorrhage, fever and pain. Secondary outcomes are the time until normal diet is resumed, the time until normal activities are resumed and the occurrence of adverse events and microbial recolonization of the tonsillar beds.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This study will enhance an 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Pan African Clinical Trials Registry, PACTR201905466349317. Retrospectively registered on 15 May 2019.\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/pactr.samrc.ac.za\/TrialDisplay.aspx?TrialID=8119\">https:\/\/pactr.samrc.ac.za\/TrialDisplay.aspx?TrialID=8119<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-019-3830-5","type":"journal-article","created":{"date-parts":[[2019,12,9]],"date-time":"2019-12-09T09:03:00Z","timestamp":1575882180000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["The effect of antibiotics on post-adenotonsillectomy morbidity in Tanzanian children: study protocol for a randomized, double-blind, placebo-controlled trial"],"prefix":"10.1186","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0771-9192","authenticated-orcid":false,"given":"Denis R.","family":"Katundu","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter S.","family":"Shija","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Baltazari","family":"Nyombi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hadija","family":"Semvua","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fieke K.","family":"Oussoren","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niels","family":"van Heerbeek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2019,12,9]]},"reference":[{"issue":"12","key":"3830_CR1","doi-asserted-by":"publisher","first-page":"1155","DOI":"10.1001\/jamapediatrics.2015.2016","volume":"169","author":"DG Ingram","year":"2015","unstructured":"Ingram DG, Friedman NR. Toward adenotonsillectomy in children: a review for the general pediatrician. JAMA Pediatr. 2015;169(12):1155\u201361.","journal-title":"JAMA Pediatr"},{"issue":"7","key":"3830_CR2","doi-asserted-by":"publisher","first-page":"338","DOI":"10.4314\/eamj.v78i7.9003","volume":"78","author":"HO Oburra","year":"2001","unstructured":"Oburra HO, Idenya M. Frequency of adenotonsillectomy in some Nairobi hospitals. East Afr Med J. 2001;78(7):338\u201342.","journal-title":"East Afr Med J"},{"issue":"4","key":"3830_CR3","doi-asserted-by":"publisher","first-page":"357","DOI":"10.1001\/jamaoto.2015.3711","volume":"142","author":"ML Rohlfing","year":"2016","unstructured":"Rohlfing ML, et al. Investigation of postoperative oral fluid intake as a predictor of postoperative emergency department visits after pediatric tonsillectomy. 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Cochrane Database Syst Rev. 2012;12:CD005607.","journal-title":"Cochrane Database Syst Rev"},{"issue":"11","key":"3830_CR6","doi-asserted-by":"publisher","first-page":"e0207465","DOI":"10.1371\/journal.pone.0207465","volume":"13","author":"PG Horumpende","year":"2018","unstructured":"Horumpende PG, et al. Prescription and non-prescription antibiotic dispensing practices in part I and part II pharmacies in Moshi Municipality, Kilimanjaro Region in Tanzania: a simulated clients approach. PLoS One. 2018;13(11):e0207465.","journal-title":"PLoS One"},{"key":"3830_CR7","unstructured":"Pynnonen M BM. Coblation versus other surgical techniques for tonsillectomy (Review). 2017;(8). Available from: http:\/\/onlinelibrary.wiley.com\/store\/10.1002\/14651858.CD004619.pub3\/asset\/CD004619.pdf?v=1&t=j9ix4oii&s=f31d35e672bd358a599dbeb4fdeaebad5966419e."},{"key":"3830_CR8","doi-asserted-by":"crossref","unstructured":"Pinder DK, Wilson H, Hilton MP. Dissection versus diathermy for tonsillectomy. 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Available from: http:\/\/doi.wiley.com\/10.1288\/00005537-199002000-00002.","DOI":"10.1288\/00005537-199002000-00002"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3830-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-019-3830-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-019-3830-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,12,7]],"date-time":"2020-12-07T19:51:11Z","timestamp":1607370671000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-019-3830-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12]]},"references-count":10,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["3830"],"URL":"https:\/\/doi.org\/10.1186\/s13063-019-3830-5","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.2.12518\/v2","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.12518\/v1","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12]]},"assertion":[{"value":"2 August 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 October 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 December 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Informed consent to participate in the study will be obtained from all parents and persons legally responsible for the participant. This research has been awarded a clearance certificate, numbered 2373, by the Kilimanjaro Christian Medical College Clinical Research Ethics and Review Committee (KCMUCo-CRERC). The trial is registered with the National institute for Medical Research (NIMR) and the Tanzanian Food and Drug Authority (TFDA), and also registered to the Pan African Clinical Trials Registry (PACTR) with registration number PACTR201905466349317 retrospectively on 15 May 2019 (\n                      \n                      ). The trial committee will monitor progress of this trial. Information obtained in this study period will only be used for study purposes.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"683"}}