Preventing ear trauma during hyperbaric oxygen therapy with pseudoephedrine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates whether pseudoephedrine can prevent middle ear trauma in patients undergoing hyperbaric oxygen therapy (HBOT). Participants will take either a pseudoephedrine pill or a placebo before their HBOT session. Their ears will be examined before and after the therapy, and they will report any ear pain experienced. The study aims to determine the effectiveness of pseudoephedrine in reducing ear-related complications during HBOT.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* New patient requiring HBOT (either inpatient or outpatient)
* Age greater than or equal to 18 years and less than 80 years
* Fluent in English
* Full decision capacity
* Able and medically cleared to swallow a pill

Exclusion Criteria:

* Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)
* Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)
* Systolic Blood Pressure \>160
* Diastolic Blood Pressure \> 90
* Heart Rate \>100
* Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
* Prisoner
* Intubated
* Unable to swallow oral medications

Where it's running

• John Muir Health
  Walnut Creek, California, United States Recruiting

Study contacts

• Principal investigator: Jacinta Showers, RN — John Muir Health
• Study coordinator: Jacinta Showers, RN
• Email: jacinta.showers@johnmuirhealth.com
• Phone: 9259473212

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.