Forty-seven patients were enrolled in this prospective, randomized, controlled study for
determining of the efficacy of Phenylephrine hydrochloride, a topical vasoconstrictor, in
preventing tympanostomy tube obstruction. Mehr 1378 to Mehr 1380, 40 patients (80 ears)
returned for postoperative evaluation. In all patients preoperative diagnosis was bilateral otitis
media with effusion. Twenty-two patients were males and 18 females. Mean age of the
patients was 5 years/old (range 3 to 10). Myringotomy with tymanostomy tube insertion was
performed in all ears. Forty control ears received no medication, but 40 treatment ears
received topical Phenylephrine immediately after the insertion of tubes. Two weeks and 2
months after surgery, tympanometry was done, and patency of tube was evaluated. The
overall incidence of tympanostomy tube obstruction was 8.75% : 5% in the treatment group
and 12.5% in the control group. That shows obstruction to be more than twice as much in the
control group.
Of course, by using Fishers exact test, based on alfa = 0.05, pvalue was 0.43, so there was
no significant difference between the two groups.
According our plan Phenylephrine drops could be efficient in prevention of ventilation tube
obstruction and safe for the inner ear.