Children 2 to 16 years of age with obstructive symptoms attributable to CATH, who did not have a history of recurrent adenotonsillitis.Design
A prospective, randomized, double-blinded, placebo-controlled trial.Setting
Ambulatory clinic of a tertiary care hospital.Intervention
Patients were randomly treated with 30-day courses of either placebo (PLAC) or AMOX/CLAV (40 mg/kg in 3 divided doses daily).Outcome Measures
Patients' signs and symptoms were assessed by physical examination and by both physician and parental forced-choice questionnaires 1, 3, and 24 months after treatment. The decision to proceed to surgery or to continue expectant management was made for all patients by the same physician, based on reported symptoms and physical findings.Results
Treatment with a 30-day course of AMOX/CLAV significantly reduced the need for surgery in the short term compared with PLAC (37.5% vs 62.7%) at 1-month follow-up). The reduced need for surgery in the AMOX/CLAV-treated group persisted at 3 months (AMOX/CLAV 54.5% vs PLAC 85.7%) and 24 months (AMOX/CLAV 83.3% vs PLAC 98.0%).Conclusions
A 30-day course of AMOX/CLAV significantly reduces the need for surgery in children with obstructive adenotonsillar hypertrophy at 1-month follow-up. This relative reduction persists at 3 and 24 months posttreatment, although the absolute percentages of patients requiring surgery increased in both groups as time after treatment increased. The reduction in symptoms in AMOX/CLAV-treated patients is modest but significant even in long-term follow-up. The precise role of this treatment for CATH is yet to be determined; however, our results suggest that a 30-day course of AMOX/CLAV can be used in situations when a temporary relief in symptoms is desirable or surgery would incur unacceptable risk. Pediatrics 1998;101:675-681.