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Randomized Controlled Trial
. 2011 Sep 6:343:d5154.
doi: 10.1136/bmj.d5154.

Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial

M T A van den Aardweg  1 , C W B Boonacker, M M Rovers, A W Hoes, A G M Schilder
Affiliations
Randomized Controlled Trial

Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial

M T A van den Aardweg et al. BMJ. .

Abstract

Objective: To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections.

Design: Open randomised controlled trial.

Setting: 11 general hospitals and two academic centres.

Participants: 111 children aged 1-6 with recurrent upper respiratory tract infections selected for adenoidectomy.

Intervention: A strategy of immediate adenoidectomy with or without myringotomy or a strategy of initial watchful waiting. Main outcome measure Primary outcome measure: number of upper respiratory tract infections per person year calculated from data obtained during the total follow-up (maximum 24 months).

Secondary outcome measures: days with upper respiratory tract infection per person year, middle ear complaints with fever in episodes and days, days with fever, prevalence of upper respiratory tract infections, and health related quality of life.

Results: During the median follow-up of 24 months, there were 7.91 episodes of upper respiratory tract infections per person year in the adenoidectomy group and 7.84 in the watchful waiting group (difference in incidence rate 0.07, 95% confidence interval -0.70 to 0.85). No relevant differences were found for days of upper respiratory tract infections and middle ear complaints with fever in episodes and days, nor for health related quality of life. The prevalence of upper respiratory tract infections decreased over time in both groups. Children in the adenoidectomy group had significantly more days with fever than the children in the watchful waiting group. Two children had complications related to surgery.

Conclusion: In children selected for adenoidectomy for recurrent upper respiratory tract infections, a strategy of immediate surgery confers no clinical benefits over a strategy of initial watchful waiting. Trial registration Dutch Trial Register NTR968: ISRCTN03720485.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. AGMS and MMR have participated in workshops and educational activities on otitis media organised by GlaxoSmithKline and have received a grant from GlaxoSmithKline for a study on the microbiology of otitis media in 2009.

Figures

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Fig 1 Flow of participants through trial of adenoidectomy in children with recurrent upper respiratory tract infections
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Fig 2 Proportion of children with upper respiratory tract infection (prevalence/week) in adenoidectomy and watchful waiting group
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