The effect of antibiotics on post-adenotonsillectomy morbidity in tanzanian children: study protocol for a randomized double-blind placebo-controlled trial.

Denis Katundu; Peter Shija; Baltazari Nyombi; Hadija Semvua; Fieke K. Oussoren; Niels van Heerbeek

doi:10.21203/rs.2.12518/v2

October 23, 2019Open Access

The effect of antibiotics on post-adenotonsillectomy morbidity in tanzanian children: study protocol for a randomized double-blind placebo-controlled trial.

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Why the study?

Postoperative prophylactic antibiotics after adenotonsillectomy were refuted in developed countries, but remain common in resource-limited settings with high infectious disease burdens, risking antibiotic resistance.

Does amoxicillin reduce postoperative morbidity (haemorrhage, fever, and pain) in children aged 2 to 14 years undergoing elective adenotonsillectomy?

Key Points

To assess the prophylactic effectiveness of postoperative antibiotics on morbidity and clinical complications following elective adenotonsillectomy in Tanzanian children.
Double-blind, randomized, placebo-controlled trial conducted at two centers in northern Tanzania: Kilimanjaro Christian Medical Centre and Arusha Lutheran Medical Centre.
Approximately 270 children aged 2 to 14 years scheduled for elective adenotonsillectomy are assigned to receive either a 5-day postoperative antibiotic regimen or placebo.
Evaluates primary outcomes of postoperative hemorrhage, fever, and pain, as well as secondary outcomes including recovery of diet and activity, adverse events, and tonsillar recolonization.
Trial protocol specifies primary outcome comparison of postoperative hemorrhage incidence, fever rates, and pain scores between the 5-day antibiotic and placebo groups.
Secondary analyses track time to resumption of normal diet and regular daily activities, adverse drug event frequency, and tonsillar bed microbial colonization patterns.

Structured PICO

Does amoxicillin reduce postoperative morbidity (haemorrhage, fever, and pain) in children aged 2 to 14 years undergoing elective adenotonsillectomy?

P

Population

Around 270 children aged 2 to 14 years, scheduled for elective (adeno)tonsillectomy in northern Tanzania.

I

Intervention

Amoxicillin 50 mg/kg body weight oral for 5 days after surgery

C

Comparator

Matching placebo for 5 days after surgery

O

Outcome

Postoperative haemorrhage, fever, and pain

This study protocol describes a randomized trial to evaluate whether routine postoperative amoxicillin reduces morbidity after adenotonsillectomy in children in a resource-limited setting.

Limitations

Loss to follow-up for children from distant areas
Different surgical techniques used by surgeons
Relatives oversee medication intake without nurse supervision
Post-operative flushing of wound bed with water is difficult to standardize

Implication

Supports omitting prophylactic antibiotics post-adenotonsillectomy in resource-limited, high-infection settings; extends Cochrane evidence to developing countries.

Abstract

Background: 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, fever and pain. Secondary outcomes are the time until normal diet is resumed, the time until normal activities are resumed, occurrence of adverse events and microbial recolonization of the tonsillar beds. 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.

Discussion

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Cite This Study

Katundu et al. (2019) studied this question.

synapsesocial.com/papers/6a72700531a3df82432a1a5c https://doi.org/10.21203/rs.2.12518/v2

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The effect of antibiotics on post-adenotonsillectomy morbidity in tanzanian children: study protocol for a randomized double-blind placebo-controlled trial.

Key Points

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

The effect of antibiotics on post-adenotonsillectomy morbidity in tanzanian children: study protocol for a randomized double-blind placebo-controlled trial.

Key Points

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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