RecruitingNot ApplicableNCT05697328

Barotrauma in Hyperbaric Oxygen Therapy

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


Sponsor

John Muir Health

Enrollment

90 participants

Start Date

Jan 31, 2023

Study Type

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

Min Age: 18 Years

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

DRUGPseudoephedrine Pill

One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

DRUGPlacebo

One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy


Locations(1)

John Muir Health

Walnut Creek, California, United States

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NCT05697328


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