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