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Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial

OBJECTIVE: To compare both approaches for the treatment of nonsevere acute otitis media (AOM) in Iran. METHODS: This randomized clinical trial was performed at a pediatric infectious diseases clinic in Buali tertiary hospital in Sari, north of Iran, from 2016 to 2018. All participants in this study...

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Autores principales: Shahbaznejad, Leila, Talaei, Ensieh, Hosseinzadeh, Fatemeh, Masoumi, Baraneh, Rezai, Shaghayegh, Rezai, Mohammad Sadegh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178009/
https://www.ncbi.nlm.nih.gov/pubmed/34135974
http://dx.doi.org/10.1155/2021/5515467
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author Shahbaznejad, Leila
Talaei, Ensieh
Hosseinzadeh, Fatemeh
Masoumi, Baraneh
Rezai, Shaghayegh
Rezai, Mohammad Sadegh
author_facet Shahbaznejad, Leila
Talaei, Ensieh
Hosseinzadeh, Fatemeh
Masoumi, Baraneh
Rezai, Shaghayegh
Rezai, Mohammad Sadegh
author_sort Shahbaznejad, Leila
collection PubMed
description OBJECTIVE: To compare both approaches for the treatment of nonsevere acute otitis media (AOM) in Iran. METHODS: This randomized clinical trial was performed at a pediatric infectious diseases clinic in Buali tertiary hospital in Sari, north of Iran, from 2016 to 2018. All participants in this study were previously healthy children with AOM diagnosis, who were 6 months to 6 years old. The patients were randomly assigned into two groups: the intervention (80 mg/kg/day amoxicillin for 7-10 days) and the control group (watchful waiting approach). AOM recovery and adverse drug reactions were evaluated after 72 hours, and the patients were followed for the frequency of AOM and middle ear effusion 1 and 3 months' postintervention. RESULTS: A total of 396 children have participated in this study. AOM recovery was significantly different in the two groups (73% vs. 44% in the intervention and control groups, respectively). Recurrence of AOM and middle ear effusion (MEE) persistence, one month following the intervention, have not shown any significant differences between the two groups. However, the AOM recurrence between 1 and 3 months was more frequent in the control group. The frequency of diarrhea was also higher in the intervention group compared to the control but no significant difference was found between the two groups regarding vomiting and skin rash. CONCLUSION: The faster recovery from AOM is achieved when an antibiotic treatment regimen is applied, although the risk of potential side effects should be considered.
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spelling pubmed-81780092021-06-15 Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial Shahbaznejad, Leila Talaei, Ensieh Hosseinzadeh, Fatemeh Masoumi, Baraneh Rezai, Shaghayegh Rezai, Mohammad Sadegh Int J Pediatr Research Article OBJECTIVE: To compare both approaches for the treatment of nonsevere acute otitis media (AOM) in Iran. METHODS: This randomized clinical trial was performed at a pediatric infectious diseases clinic in Buali tertiary hospital in Sari, north of Iran, from 2016 to 2018. All participants in this study were previously healthy children with AOM diagnosis, who were 6 months to 6 years old. The patients were randomly assigned into two groups: the intervention (80 mg/kg/day amoxicillin for 7-10 days) and the control group (watchful waiting approach). AOM recovery and adverse drug reactions were evaluated after 72 hours, and the patients were followed for the frequency of AOM and middle ear effusion 1 and 3 months' postintervention. RESULTS: A total of 396 children have participated in this study. AOM recovery was significantly different in the two groups (73% vs. 44% in the intervention and control groups, respectively). Recurrence of AOM and middle ear effusion (MEE) persistence, one month following the intervention, have not shown any significant differences between the two groups. However, the AOM recurrence between 1 and 3 months was more frequent in the control group. The frequency of diarrhea was also higher in the intervention group compared to the control but no significant difference was found between the two groups regarding vomiting and skin rash. CONCLUSION: The faster recovery from AOM is achieved when an antibiotic treatment regimen is applied, although the risk of potential side effects should be considered. Hindawi 2021-05-27 /pmc/articles/PMC8178009/ /pubmed/34135974 http://dx.doi.org/10.1155/2021/5515467 Text en Copyright © 2021 Leila Shahbaznejad et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Shahbaznejad, Leila
Talaei, Ensieh
Hosseinzadeh, Fatemeh
Masoumi, Baraneh
Rezai, Shaghayegh
Rezai, Mohammad Sadegh
Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial
title Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial
title_full Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial
title_fullStr Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial
title_full_unstemmed Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial
title_short Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A Randomized Clinical Trial
title_sort comparing watchful waiting approach vs. antibiotic therapy in children with nonsevere acute otitis media: a randomized clinical trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178009/
https://www.ncbi.nlm.nih.gov/pubmed/34135974
http://dx.doi.org/10.1155/2021/5515467
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