The purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during HBOT. Pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure.
Subjects will be asked to take a pill (pseudoephedrine or placebo) between 45 and 120 minutes before hyperbaric oxygen therapy. Subjects' ears will be examined before and after therapy and be asked to assess ear pain. There will be no further tests or procedures after completion of therapy session and ear examinations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
90
One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
John Muir Health
Walnut Creek, California, United States
RECRUITINGCompare changes in self-reported ear pain during hyperbaric oxygen therapy
Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy
Time frame: 45-60 minutes
Incidence of completed compression
Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.
Time frame: 1 minute
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