Modified adenotonsillectomy to improve cure rates for pediatric obstructive sleep apnea: a randomized controlled trial

Abstract

Objective: To compare the efficacy of adenotonsillectomy (T&A) with and without pharyngoplasty (tonsillar pillar closure) in the treatment of pediatric obstructive sleep apnea-hypopnea syndrome (OSAHS).

Study design: Randomized single-blind controlled study.

Setting: Tertiary care center.

Subjects and methods: Sixty pediatric patients with a clinical diagnosis of OSAHS presenting between January 2009 and December 2010 were enrolled and randomized to undergo either standard T&A (n = 30) or T&A with pharyngoplasty (n = 30). Surgical cure was defined as apnea-hypopnea index (AHI) <5 plus OSA-18 health-related quality-of-life (HRQL) score <60. Other outcomes included postsurgical AHI and minimum oxygen saturation (SpO(2)) improvement, changes in OSA-18 scores at 1 month, and postsurgical days to resume normal diet and activity.

Results: Three patients from each group did not undergo surgery. Of the 54 patients treated, 8 from the pharyngoplasty group and 2 from the standard group were lost to follow-up. Intention-to-treat analysis revealed no difference in cure rate between groups (standard 60%, pharyngoplasty 56.6%, P = .793). Limiting analysis to those patients with complete data, a higher, but not significantly increased, cure rate with pharyngoplasty was noted (72% vs 89.5%, P = .155). Greater OSA-18 improvement (P = .036) and greater (although nonsignificant) AHI improvement and earlier return to normal function were noted with pharyngoplasty.

Conclusion: The addition of pharyngoplasty to traditional adenotonsillectomy did not significantly improve OSAHS cure rates as measured by sleep testing and HRQL, although a nonsignificant increase in cure rate was observed in those who completed the study protocol. An unexpectedly high rate of patient dropout rendered the study statistically underpowered and therefore inconclusive.