Objective: To determine the efficacy of phenylephrine hydrochloride, a topical vasoconstrictor, in preventing tympanostomy tube obstruction.
Design: Prospective, randomized, double-blind, controlled trial of patients undergoing myringotomy with tympanostomy tube insertion.
Setting: Academic, tertiary referral medical center.
Patients: Two hundred eight patients were enrolled in the study; 157 patients (310 ears) returned for postoperative evaluation.
Interventions: Myringotomy with tympanostomy tube insertion was performed in all ears: 139 control ears received ototopical antibiotics and 171 treatment ears received ototopical antibiotics plus topical phenylephrine.
Main outcome measure: Postoperative tympanostomy tube obstruction.
Results: The overall incidence of tympanostomy tube obstruction was 5.2%: 8.6% in the control group and 2.3% in the treatment group. The treatment group demonstrated an odds ratio of 0.25 (95% confidence interval, 0.08-0.78; P= .02).
Conclusion: The use of phenylephrine following tympanostomy tube insertion greatly reduces the incidence of tube obstruction.