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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pseudoephedrine | Experimental | over the counter pseudoephedrine |
|
| Placebo | Placebo Comparator | pharmacy created placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pseudoephedrine Pill | Drug | One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of completed compression | Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain. | 1 minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacinta Showers, RN | Contact | 9259473212 | jacinta.showers@johnmuirhealth.com | |
| Todd Kessinger, MD, MD | Contact | 9259473212 | todd.kessinger_MD@johnmuirhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Jacinta Showers, RN | John Muir Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Health | Recruiting | Walnut Creek | California | 94598 | United States |
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| ID | Term |
|---|---|
| D001469 | Barotrauma |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D054199 | Pseudoephedrine |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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prospective randomized double-blind placebo control study design (enrollment ratio 1:1)
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double-blind placebo control
| Placebo | Drug | One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy |
|
| D020005 |
| Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |