A double-blind randomized placebo-controlled trial of topical intranasal mometasone furoate nasal spray in children of adenoidal hypertrophy with otitis media with effusion.

Abstract

PURPOSE:

To study the effects of topical intranasal mometasone furoate nasal spray for management of otitis media with effusion in children aged 2-12 years with adenoidal hypertrophy and its impact on change in quality of life.

METHOD:

A prospective randomized double blind interventional placebo control study was conducted. Hundred patients of endoscopic grade 3 or 4 adenoidal hypertrophy aged 2-12 years were enrolled in this study. Among these sixty two patients had persistent bilateral otitis media with effusion more than three months. These were randomly divided into two groups, group A and group B. Group A received mometasone nasal spray for six months and group B received saline nasal spray for the same period. Patients were evaluated with symptom, pure tone audiometry wherever possible, pneumatic otoscopic examination and tympanogram at 0, 8 and 24 weeks.

RESULTS:

Resolution of otitis media with effusion in study group (28 out of 30) was significantly higher as compared control group (16 out of 32) (p value 0.0004). A significant improvement in hearing and symptoms was seen in the study group (p<0.04). Statistically significant change in quality of life was seen with mometasone nasal spray (37.11) as compared to saline nasal spray (11.02) (p value 0.0001).

CONCLUSION:

Mometasone nasal spray appears to be effective for the treatment of otitis media with effusion in patients of adenoidal hypertrophy.

• Authors: Rahul Bhargava, Arunabha Chakravarti
• Journal: American journal of otolaryngology (Am J Otolaryngol) 2014 Nov-Dec Vol. 35 Issue 6 Pg. 766-70 ISSN: 1532-818X [Electronic] United States
• PMID: 25151658 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Chemical References

• Anti-Inflammatory Agents
• Nasal Sprays
• Pregnadienediols
• Mometasone Furoate

Topics

• Adenoids (pathology)
• Administration, Topical
• Anti-Inflammatory Agents (administration & dosage)
• Child
• Child, Preschool
• Double-Blind Method
• Female
• Humans
• Hypertrophy
• Male
• Mometasone Furoate
• Nasal Sprays
• Otitis Media with Effusion (drug therapy)
• Pregnadienediols (administration & dosage)
• Quality of Life
• Treatment Outcome