The efficacy of oral montelukast versus intranasal fluticasone furoate in reducing the severity of pediatric sleep-disordered breathing: A randomized clinical trial.

Objectives

To compare the clinical efficacy of oral montelukast versus intranasal fluticasone furoate in reducing the severity of sleep-disordered breathing (SDB) among children with adenotonsillar hypertrophy.

Methods

A prospective randomized clinical trial was conducted between 9/2022 and 4/2023, including children aged 2-15 years with SDB and adenotonsillar hypertrophy. At baseline, all participants underwent symptom assessment using the Pediatric Sleep Questionnaire (PSQ), followed by physical examination. Subjects were randomized to receive either oral montelukast or intranasal fluticasone furoate for two months. Following treatment, the children were re-evaluated, and if no clinical improvement was observed, surgery was scheduled.

Results

Sixty-seven children with a mean age of 5.25 years (45, 67% males) were included. The median PSQ score improved in the montelukast group from 0.45 to 0.28 (p = 0.003) and in the fluticasone furoate group from 0.43 to 0.36 (p = 0.006) with comparable efficacy (p = 0.292). The prevalence of moderate-to-severe sleep apnea decreased from 67% to 41% with montelukast (p = 0.035) and from 81% to 60% with fluticasone furoate (p = 0.016). While both medications significantly reduced adenoid size (p < 0.001 and p < 0.001, respectively), only montelukast significantly reduced tonsillar size (p = 0.008).

Conclusions

Both montelukast and fluticasone furoate reduced the pediatric SDB severity. While both medications significantly decreased adenoid size, only montelukast significantly decreased tonsillar size. Therefore, fluticasone furoate may be appropriate for adenoid hypertrophy, while montelukast is favored for concurrent tonsillar hypertrophy. These treatments may serve as alternatives to surgery in selected cases. Further studies are needed to evaluate their long-term efficacy.