Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children: a randomized controlled trial
Open accessAbstract
BACKGROUND: Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. OBJECTIVE: To compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran. METHODS: This randomized controlled trial was done on 2- to 6-year-old children attending Koodakan Hospital in Bandar Abbas, southern Iran, in 2014. Patients were divided into three groups of montelukast, mometasone, and control group. Audiometry was done for all patients at baseline and four weeks after treatment. Patients were compared for treatment results. Data were analyzed using SPSS 21.0 software. RESULTS: A total of 143 children were included in the study. Mean age of the participants were 44.64 ± 18.03 months. There was no significant difference in treatment results in different treatment groups (p>0.05). CONCLUSION: Mometasone and montelukast are not effective and not recommended in treatment of otitis media with effusion in children. More studies are needed in this regard. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov with ClinicalTrials.gov Identifier: NCT02541760. FUNDING: The authors received financial support for this research from Hormozgan University of Medical Sciences.
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In Rahmati 2017, the risk of bias for allocation concealment (selection bias) was unclear because there was insufficient information about the sequence generation process.
“Allocation concealment (selection bias) Unclear risk Insufficient information about the sequence generation process to permit judgement.”
From Topical and oral steroids for otitis media with effusion (OME) in children (2023) · cites this paper as Rahmati 2017
Section 2.4, “Randomization and intervention” (page unavailable), says participants were randomly assigned to three groups but gives no sequence-generation or allocation-concealment procedure. That supports the stated lack of information; the paper does not itself assess allocation concealment as having unclear risk of bias. (LLM, conf=0.83)
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Cites
Simpson, S. A., Lewis, R., van der Voort, J., & Butler, C. C. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001935.pub3 · Cited by 184 · see citing works
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Topical and oral steroids for otitis media with effusion (OME) in children
Mulvaney, C. A., Galbraith, K., Webster, K. E., Rana, M., Connolly, R., Tudor-Green, B., Marom, T., Daniel, M., Venekamp, R. P., Schilder, A. G., et al. (2023) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015255.pub2 · Cited by 18 · see citing works
- Authors
- Bagher Rahmati, M., Safdarian, F., Shiroui, B., Zare, S., & Sadeghi, N.
- Affiliations
- Hormozgan University of Medical Sciences (IR)
- Corresponding author
- Shiroui, Babak
- ORCID
- Zare, Shahram
- Venue
- Electronic Physician
- Publisher
- Knowledge Kingdom Publishing
- Published
- 2017-07-25
- Volume
- 9
- Issue
- 7
- Pages
- 4890-4894
- ISSN
- 2008-5842 (ISSN-L)
- PMC
- PMC5587009
- OpenAlex
- W2747925542
- Cited by
- 5
- References
- 1
- Citations by year
- 2026: 1 · 2023: 2 · 2022: 1 · 2021: 1
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Electronic physician (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- Hormozgan University of Medical Sciences
- Topics
- Health Sciences › Medicine › Otorhinolaryngology › Ear Surgery and Otitis Media
- Health Sciences › Health Professions › Emergency Medical Services › Pediatric health and respiratory diseases
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Keywords
- otitis media with effusion, montelukast, children, leukotriene receptor antagonists, corticosteroid nasal spray, audiometry, treatment efficacy
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