STUDY OBJECTIVE: To determine the efficacy of topical nasal decongestant in the prevention of middle ear barotrauma in patients undergoing hyperbaric oxygen therapy. DESIGN: Prospective, parallel, double-blind, randomized trial. SETTING: University-affiliated community hospital emergency department with hyperbaric oxygen facilities. PARTICIPANTS: Sixty patients undergoing hyperbaric oxygen therapy; 30 subjects in each treatment arm. INTERVENTIONS: After randomization, consenting patients were given two sprays of oxymetazoline hydrochloride or sterile water, 15 minutes before hyperbaric oxygen therapy. Collected data included patient demographics, ear examinations before and after hyperbaric oxygen treatment, and subjective ear complaints. The otoscopic appearance of the tympanic membrane was graded according to the amount of hemorrhage in the eardrum, with Teed scores ranging from 0 (symptoms only) to 5 (gross hemorrhage and rupture). RESULTS: The treatment groups were similar with regard to age, sex, and medical history. Ear discomfort during hyperbaric oxygen therapy was present in 63% (19 of 30) of those receiving oxymetazoline versus 67% (20 of 30) of the control group (P = .99). Likewise, both groups had similar Teed scores after hyperbaric oxygen therapy (P = .88). No adverse effects were noted. CONCLUSION: The results of this pilot study suggest that topical decongestants may not be effective in preventing middle ear barotrauma during hyperbaric oxygen therapy.
RCT Entities:
STUDY OBJECTIVE: To determine the efficacy of topical nasal decongestant in the prevention of middle ear barotrauma in patients undergoing hyperbaric oxygen therapy. DESIGN: Prospective, parallel, double-blind, randomized trial. SETTING: University-affiliated community hospital emergency department with hyperbaric oxygen facilities. PARTICIPANTS: Sixty patients undergoing hyperbaric oxygen therapy; 30 subjects in each treatment arm. INTERVENTIONS: After randomization, consenting patients were given two sprays of oxymetazoline hydrochloride or sterile water, 15 minutes before hyperbaric oxygen therapy. Collected data included patient demographics, ear examinations before and after hyperbaric oxygen treatment, and subjective ear complaints. The otoscopic appearance of the tympanic membrane was graded according to the amount of hemorrhage in the eardrum, with Teed scores ranging from 0 (symptoms only) to 5 (gross hemorrhage and rupture). RESULTS: The treatment groups were similar with regard to age, sex, and medical history. Ear discomfort during hyperbaric oxygen therapy was present in 63% (19 of 30) of those receiving oxymetazoline versus 67% (20 of 30) of the control group (P = .99). Likewise, both groups had similar Teed scores after hyperbaric oxygen therapy (P = .88). No adverse effects were noted. CONCLUSION: The results of this pilot study suggest that topical decongestants may not be effective in preventing middle ear barotrauma during hyperbaric oxygen therapy.