1

Introduction

Patient non-adherence with prescribed drug therapy is a significant cause of treatment failure . Pain associated with drug product administration is a specific impediment to adherence. While it is not commonly observed, severe pain associated with administration of topical medications can affect therapeutic outcomes.

2

Case presentation

We report a case of a 59 year-old male who presented to the clinic with bilateral otorrhea, fullness, and hearing loss on the right side. The patient is currently being treated with ustekinumab for extensive plaque psoriasis. The past medical history was significant for bilateral tympanostomy tube insertions to treat chronic otitis media with effusion. Bilateral tympanic membrane perforations persisted after the tubes were removed. Binocular microscopic examination demonstrated white, moist debris filling the ear canals consistent with fungal otitis externa. The ear canals were cleaned thoroughly. Cultures were not obtained. Clotrimazole 1% topical solution was prescribed at a dose of four drops three times a day. The patient was advised to keep the ears dry and to avoid scratching the affected areas. The patient was informed he could expect discomfort upon medication application.

The patient returned one week later for a follow-up visit. Visual examination demonstrated only slight improvement in the infection. The patient described severe and persistent otalgia with administration of the clotrimazole solution. The pain originated deep in the ear and radiated into the nasopharynx and neck. The patient also reported an unpleasant taste following clotrimazole solution use. The painful sensation lasted approximately 30 min after each use. Oral ibuprofen did not alleviate the pain. As a result, the patient used the drops less frequently than prescribed. Poor adherence likely contributed to the minimal improvement in his condition.

The patient, who holds a Ph.D. in pharmaceutical science, inquired about adjunctive therapy to mitigate the pain associated with the clotrimazole therapy and suggested the use of topical tetracaine. In light of his tympanic perforations and the immunosuppressive side-effects associated with ustekinumab, the risk associated with topical tetracaine therapy was considered acceptable compared to the potential consequences of an untreated fungal otitis externa in this patient. It was agreed that a trial therapy with tetracaine 1% in propylene glycol (PG) would be attempted. The product is not commercially available, so the patient received the medication from a compounding pharmacist. The patient used two drops of tetracaine five minutes prior to using the clotrimazole.

One week later, the visual examination was notable for a significant improvement of the infection, with minimal fungal debris noted. The patient reported that the tetracaine solution caused mild transient discomfort upon instillation, but it rendered the clotrimazole treatment painless. The patient was able to complete the remainder of the three-week treatment regimen as prescribed. The patient reported no other side effects associated with the use of the tetracaine solution.

2

Case presentation

We report a case of a 59 year-old male who presented to the clinic with bilateral otorrhea, fullness, and hearing loss on the right side. The patient is currently being treated with ustekinumab for extensive plaque psoriasis. The past medical history was significant for bilateral tympanostomy tube insertions to treat chronic otitis media with effusion. Bilateral tympanic membrane perforations persisted after the tubes were removed. Binocular microscopic examination demonstrated white, moist debris filling the ear canals consistent with fungal otitis externa. The ear canals were cleaned thoroughly. Cultures were not obtained. Clotrimazole 1% topical solution was prescribed at a dose of four drops three times a day. The patient was advised to keep the ears dry and to avoid scratching the affected areas. The patient was informed he could expect discomfort upon medication application.

The patient returned one week later for a follow-up visit. Visual examination demonstrated only slight improvement in the infection. The patient described severe and persistent otalgia with administration of the clotrimazole solution. The pain originated deep in the ear and radiated into the nasopharynx and neck. The patient also reported an unpleasant taste following clotrimazole solution use. The painful sensation lasted approximately 30 min after each use. Oral ibuprofen did not alleviate the pain. As a result, the patient used the drops less frequently than prescribed. Poor adherence likely contributed to the minimal improvement in his condition.

The patient, who holds a Ph.D. in pharmaceutical science, inquired about adjunctive therapy to mitigate the pain associated with the clotrimazole therapy and suggested the use of topical tetracaine. In light of his tympanic perforations and the immunosuppressive side-effects associated with ustekinumab, the risk associated with topical tetracaine therapy was considered acceptable compared to the potential consequences of an untreated fungal otitis externa in this patient. It was agreed that a trial therapy with tetracaine 1% in propylene glycol (PG) would be attempted. The product is not commercially available, so the patient received the medication from a compounding pharmacist. The patient used two drops of tetracaine five minutes prior to using the clotrimazole.

One week later, the visual examination was notable for a significant improvement of the infection, with minimal fungal debris noted. The patient reported that the tetracaine solution caused mild transient discomfort upon instillation, but it rendered the clotrimazole treatment painless. The patient was able to complete the remainder of the three-week treatment regimen as prescribed. The patient reported no other side effects associated with the use of the tetracaine solution.