Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy

Description:

Aim 1: To investigate the efficacy of pre-treatment with oral pseudoephedrine 60mg for decreasing MEB during HBOT.

Hypothesis: Patients randomized to pseudoephedrine will have a lesser need for oxymetazoline rescue therapy while being compressed. They will also report  less ear pain once at pressure
compared to patients receiving placebo.

Aim 2: To measure the incidence of MEB during HBOT. The investigators will also identify factors (age, gender, medical history) that could predispose an individual to developing MEB during HBOT.

Hypothesis: The incidence of MEB defined as requiring stopping compression of the chamber and oxymetazoline rescue will be greater than 30%. Female sex, age above 60, and prior history of ear conditions will be associated with development of MEB.

Condition:

Barotrauma;Ear

Treatment:

Hyperbaric Oxygen Therapy

Start Date:

June 1, 2020

Sponsor:

University of Maryland, Baltimore

For More Information:

https://clinicaltrials.gov/show/NCT04332211

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