Montelukast versus inhaled mometasone for treatment of otitis media with effusion in children

A randomized controlled trial

Authors

  • Babak Shiroui Pediatrician ,Clinical Research Development Center Of Children Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran

Keywords:

Mometasone, Montelukast, Otitis media, Effusion

Abstract

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.

References

Simasek M, Blandino DA. Treatment of the common cold. Am Fam Physician. 2007; 75(4): 515-20.

PMID: 17323712.

Coker TR, Chan LS, Newberry SJ, Limbos MA, Suttorp MJ, Shekelle PG, et al. Diagnosis, microbial

epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review. JAMA. 2010;

(19): 2161-9. doi: 10.1001/jama.2010.1651. PMID: 21081729.

Casselbrant ML, Mandel EM, Rockette HE, Kurs-Lasky M, Fall PA, Bluestone CD. Adenoidectomy for

otitis media with effusion in 2-3-year-old children. Int J Pediatr Otorhinolaryngol. 2009; 73(12): 1718-24.

doi: 10.1016/j.ijporl.2009.09.007. PMID: 19819563, PMCID: PMC2787742.

Thomas CL, Simpson S, Butler CC, van der Voort JH. Oral or topical nasal steroids for hearing loss

associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2006; (3): CD001935.

doi: 10.1002/14651858.CD001935.pub2. PMID: 16855980.

American Academy of Family P, American Academy of O-H, Neck S, American Academy of Pediatrics

Subcommittee on Otitis Media With E. Otitis media with effusion. Pediatrics. 2004; 113(5): 1412-29.

PMID: 15121966.

Mandel EM, Casselbrant ML, Rockette HE, Fireman P, Kurs-Lasky M, Bluestone CD. Systemic steroid for

chronic otitis media with effusion in children. Pediatrics. 2002; 110(6): 1071-80. PMID: 12456902.

Fireman P. Effect of early or delayed insertion of tympanostomy tubes. Curr Allergy Asthma Rep. 2002;

(4): 295-6. PMID: 12044263.

Butler CC, Van Der Voort JH. Oral or topical nasal steroids for hearing loss associated with otitis media

with effusion in children. Cochrane Database Syst Rev. 2002; (4): CD001935. doi:

1002/14651858.CD001935. PMID: 12519563.

Tapiainen T, Kujala T, Renko M, Koivunen P, Kontiokari T, Kristo A, et al. Effect of antimicrobial

treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial.

JAMA Pediatr. 2014; 168(7): 635-41. doi: 10.1001/jamapediatrics.2013.5311. PMID: 24797294.

Bhargava R, Chakravarti A. A double-blind randomized placebo-controlled trial of topical intranasal

mometasone furoate nasal spray in children of adenoidal hypertrophy with otitis media with effusion. Am J

Otolaryngol. 2014; 35(6): 766-70. doi: 10.1016/j.amjoto.2014.06.006. PMID: 25151658.

Ucar S, Huseynov T, Coban M, Sarioglu S, Serbetcioglu B, Yalcin AD. Montelukast is as effective as

penicillin in treatment of acute otitis media: an experimental rat study. Med Sci Monit Basic Res. 2013; 19:

-52. doi: 10.12659/MSMBR.889474. PMID: 24048018, PMCID: PMC3808231.

Simpson SA, Lewis R, van der Voort J, Butler CC. Oral or topical nasal steroids for hearing loss associated

with otitis media with effusion in children. Cochrane Database Syst Rev. 2011; (5): CD001935. doi:

1002/14651858.CD001935.pub3. PMID: 21563132.

Leach AJ, Morris PS, Mathews JD, Chronic Otitis Media Intervention Trial - One g. Compared to placebo,

long-term antibiotics resolve otitis media with effusion (OME) and prevent acute otitis media with

perforation (AOMwiP) in a high-risk population: a randomized controlled trial. BMC Pediatr. 2008; 8: 23.

doi: 10.1186/1471-2431-8-23. PMID: 18513453, PMCID: PMC2443129.

Daniel M. Antibiotics for otitis media with effusion in children. Clin Otolaryngol. 2013; 38(1): 56-7. doi:

1111/coa.12069. PMID: 23418968.

Van Zon A, van der Heijden GJ, van Dongen TM, Burton MJ, Schilder AG. Antibiotics for otitis media

with effusion in children. Cochrane Database Syst Rev. 2012; 9: CD009163. doi:

1002/14651858.CD009163.pub2. PMID: 22972136.

Wallace IF, Berkman ND, Lohr KN, Harrison MF, Kimple AJ, Steiner MJ. Surgical treatments for otitis

media with effusion: a systematic review. Pediatrics. 2014; 133(2): 296-311. doi: 10.1542/peds.2013-3228.

PMID: 24394689.

Ertugay CK, Cingi C, Yaz A, San T, Ulusoy S, Erdogmus N, et al. Effect of combination of montelukast

and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial. Acta Otolaryngol.

; 133(12): 1266-72. doi: 10.3109/00016489.2013.824113. PMID: 23972320.

Aynali G, Yariktas M, Yasan H, Karahan N, Baspinar S, Tuz M, et al. The effects of methylprednisolone,

montelukast and indomethacine in experimental otitis media with effusion. Int J Pediatr Otorhinolaryngol.

; 75(1): 15-9. doi: 10.1016/j.ijporl.2010.09.024. PMID: 21036406.

Schoem SR, Willard A, Combs JT. A prospective, randomized, placebo-controlled, double-blind study of

montelukast's effect on persistent middle ear effusion. Ear Nose Throat J. 2010; 89(9): 434-7. PMID:

Combs JT. The effect of montelukast sodium on the duration of effusion of otitis media. Clin Pediatr

(Phila). 2004; 43(6): 529-33. PMID: 15248005.

Published

2022-01-18

Issue

Section

Articles