Barotrauma in Hyperbaric Oxygen Therapy

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05697328

Acronym

HBOT

Enrollment

Registered

2023-01-25

Start date

2023-01-31

Completion date

2026-07-31

Last updated

2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barotrauma

Keywords

hyperbaric oxygen therapy

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.

Detailed description

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double-blind placebo control

Intervention model description

prospective randomized double-blind placebo control study design (enrollment ratio 1:1)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Compare changes in self-reported ear pain during hyperbaric oxygen therapy	45-60 minutes	Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy

Secondary

Measure	Time frame	Description
Incidence of completed compression	1 minute	Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.

Countries

United States

Contacts

Primary ContactJacinta Showers, RN

jacinta.showers@johnmuirhealth.com9259473212

Backup ContactTodd Kessinger, MD, MD

todd.kessinger_MD@johnmuirhealth.com9259473212

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026