Recruiting

Pseudoephedrine

Sponsor:

John Muir Health

Code:

NCT05697328

Conditions

Barotrauma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pseudoephedrine Pill

Placebo

Study Details

Brief 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.

Conditions

Barotrauma

Study ID

NCT05697328

Start date

Jan 31, 2023

Status verified date

Aug, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Pseudoephedrine

over the counter pseudoephedrine

placebo comparator: Placebo

pharmacy created placebo capsule

Interventions

Pseudoephedrine Pill

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

Placebo

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

Primary outcome measure

  • Compare changes in self-reported ear pain during hyperbaric oxygen therapy [ Time Frame: 45-60 minutes ]

Central Contacts and Locations

Central contacts

Jacinta Showers, RN

9259473212jacinta.showers@johnmuirhealth.com

Todd Kessinger, MD, MD

9259473212todd.kessinger_MD@johnmuirhealth.com

Locations

John Muir Health

Recruiting

Walnut Creek, California, United States, 94598

Contacts

Jacinta Showers, RN

9259473212jacinta.showers@johnmuirhealth.com

Todd Kessinger, MD

9259473212todd.kessinger_MD@johnmuirhealth.com

Principal Investigator:

Jacinta Showers, RN

More Information

Sponsor

John Muir Health

Last update posted

Aug 27, 2025

Last verified

Aug, 2025

Keywords

  • hyperbaric oxygen therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John Muir Health on 2025-08-27.