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NCT05697328
Barotrauma in Hyperbaric Oxygen Therapy
Conditions: Barotrauma
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 90
Sponsor: John Muir Health
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 Criteria
Inclusion Criteria:New patient requiring HBOT (either inpatient or outpatient)Age greater than or equal to 18 years and less than 80 yearsFluent in EnglishFull decision capacityAble and medically cleared to swallow a pillExclusion 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 >160Diastolic Blood Pressure > 90Heart Rate >100Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.PrisonerIntubatedUnable to swallow oral medications
Source: ClinicalTrials.gov (NCT05697328). StuddyBuddy aggregates publicly available trial information.