1. In a randomized controlled trial of children with sleep-disordered breathings, intranasal saline and intranasal corticosteroids were equally efficacious.

2. Both treatment groups had similar rates of parental satisfaction, parental and surgeon perception of the need for surgery, and rates of adverse events.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Sleep-disordered breathing (SDB), which includes snoring and obstructive sleep apnea (OSA) is common in children and impacts cognition, behavior, and cardiovascular health. Adenotonsillectomy (T&A) is the standard of care for managing moderate to severe OSA. Previous small-sized clinical trials suggest that intranasal corticosteroids may improve SDB when the diagnosis is supported by polysomnography (PSG) findings. However, pediatric PSG is often difficult to attain, especially in smaller pediatric centers. This randomized controlled trial evaluated the use of intranasal saline or corticosteroids in children with SDB symptoms regardless of PSG evaluation. Following 6 weeks of treatment, both groups had resolution of SDB symptoms in 40 to 44%% of participants. There were no differences in standardized SDB-related scores, parental satisfaction, perception of the need for surgery (from parents or surgeons), or rates of adverse events. One limitation is the exclusion of participants with severe SDB or body mass index (BMI) greater than the 97th percentile, which limits the generalizability. Overall, this study suggests that intranasal glucocorticoids may not be more effective than saline spray for the treatment of SDB in children. The resolution of symptoms regardless of therapy type suggests that either nasal saline provides some therapeutic benefit or that SDB resolves over time in a significant proportion of children.

Click here to read the article in JAMA Pediatrics

Relevant Reading: Diagnosis and management of childhood obstructive sleep apnea syndrome

In-Depth [randomized controlled trial]: The MIST trial was a multi-center randomized double-blinded, placebo-controlled trial in Australia that included participants aged 3-12 years old who were referred to a specialist for SDB symptoms between 2018 and 2020. Participants were allocated to two groups with either one intranasal spray daily per nostril of (1) mometasone furoate (50 μg dose) or (2) saline for 6 weeks duration. 138 participants were randomized to each treatment group. The primary outcome was the proportion of participants with resolution of significant SDB symptoms. Secondary outcomes included SDB symptoms based on functional and behavioral performance and validated standardized scales ( Pediatric Sleep Questionnaire–SDB subscale (PSQ-SDB) and the OSA-11 and OSA-522 subset of the quality of life (PedsQL) scale). Other secondary measures included parental perception of their child’s need for surgery, willingness to proceed to surgery, and parent-perceived benefit from treatment measured by the Glasgow Child Benefit Inventory. Primary outcomes did not differ between treatment groups with 40% and 44% of participants without significant symptoms (compared to 0 participants in each group at baseline) in mometasone furoate and saline groups, respectively. No differences were seen regarding surgeon consensus for surgery at follow-up, parental perception of the need for surgery, parental satisfaction, or SDB symptoms measured by standardized scales. Rates of adverse events did not differ between groups and were most commonly epistaxis and nasal itch/irritation.

Image: PD

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