Is intranasal steroid (INS) safe for use in children less than 2 years old with adenoid hypertrophy?

Safety of Intranasal Steroids in Children Under 2 Years for Adenoid Hypertrophy

Intranasal steroids are not FDA-approved for children under 2 years of age and should not be used in this population for adenoid hypertrophy. 1

FDA-Approved Age Restrictions

The FDA drug label for mometasone furoate explicitly states that children under 2 years of age should not use intranasal corticosteroids. 1 The approved dosing begins at age 2 years and older, with 1 spray per nostril once daily for children aged 2-11 years. 1

Guideline Recommendations

No major clinical practice guidelines recommend intranasal steroids for children under 2 years. The American Academy of Otolaryngology-Head and Neck Surgery guidelines for otitis media with effusion (which often coexists with adenoid hypertrophy) specifically recommend against using intranasal steroids for treating middle ear effusion in the general pediatric population. 2

For surgical management in children under 4 years old with adenoid-related symptoms, guidelines recommend tympanostomy tubes when surgery is performed, and adenoidectomy should only be performed if a distinct indication exists (such as nasal obstruction or chronic adenoiditis) beyond middle ear disease alone. 2

Available Evidence in Young Children

The evidence base for intranasal steroids in very young children with adenoid hypertrophy is extremely limited:

• One retrospective study examined Maxitrol® drops (a combination product containing dexamethasone, not a standard intranasal corticosteroid) in 86 children under 2 years with adenoid hypertrophy. 3 While no growth suppression or eye complications were reported during one year of follow-up, most patients eventually required surgery (odds ratio for surgery 1.394 for those using the medication). 3

• The Cochrane systematic review on intranasal corticosteroids for adenoidal hypertrophy included children aged 0-12 years, but the actual age range of participants in the included trials was not specified as starting below 2 years. 4

Safety Concerns in This Age Group

The primary concerns for using intranasal steroids in children under 2 years include:

• Growth suppression risk: Children aged 2-11 years using intranasal steroids should use them for the shortest time necessary, as growth rate may be slower during use. 1 This concern is amplified in children under 2 years during a critical growth period.

• Lack of safety data: Standard intranasal corticosteroids (mometasone, fluticasone, budesonide) have not been adequately studied in children under 2 years for safety or efficacy. 1

• Hypothalamic-pituitary-adrenal axis effects: While studies show no HPA axis suppression at recommended doses in older children, 5 no such data exist for infants and toddlers under 2 years.

Clinical Management Algorithm for Children Under 2 Years

For children under 2 years with adenoid hypertrophy:

1. Watchful waiting is appropriate for mild symptoms without sleep-disordered breathing or significant complications. 2

2. Evaluate for at-risk conditions including baseline sensory, physical, cognitive, or behavioral factors that increase risk for speech, language, or learning problems. 2

3. Obtain age-appropriate hearing testing if symptoms persist or if the child is at risk. 2

4. Consider adenoidectomy only when distinct indications exist such as severe nasal obstruction, chronic adenoiditis, or documented obstructive sleep apnea. 2

5. Do not use intranasal corticosteroids as they are contraindicated by FDA labeling in this age group. 1

Important Caveats

The European Respiratory Society recommends intranasal steroids for childhood obstructive sleep apnea in the presence of adenoid hypertrophy and co-existing rhinitis, 2 but this recommendation applies to older children, not infants under 2 years. The evidence supporting intranasal steroids shows efficacy in children aged 1-14 years, 2 but the lower age limit of actual study participants and FDA approval remains at 2 years. 1

Adenoid hypertrophy must be considered in the context of other conditions such as allergic rhinitis, otitis media with effusion, and sleep-disordered breathing. 2 However, treatment of these associated conditions in children under 2 years should not include intranasal corticosteroids due to age restrictions. 1