Barotrauma in Hyperbaric Oxygen Therapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Barotrauma

Intervention / Treatment
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* Drug: Pseudoephedrine Pill
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized double-blind placebo control study design (enrollment ratio 1:1)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pseudoephedrine<br>over the counter pseudoephedrine | Drug: Pseudoephedrine Pill<br>* One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy<br>* Other names: Sudafed;|
| Placebo Comparator: Placebo<br>pharmacy created placebo capsule | Drug: Placebo<br>* One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperbaric oxygen therapy