Barotrauma in Hyperbaric Oxygen Therapy
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
John Muir Health
90 participants
Jan 31, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria9
- 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
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05697328