Status:
COMPLETED
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Barotrauma;Ear
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atm for the treatment of various emergent medical conditions including carbon monoxide poisoning. The most c...
Detailed Description
Aim 1: To investigate the efficacy of pre-treatment with oral pseudoephedrine 60mg for decreasing MEB during HBOT. Hypothesis: Patients randomized to pseudoephedrine will have a lesser need for oxyme...
Eligibility Criteria
Inclusion
- 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
- Contraindication to pseudoephedrine (MAOI use, pregnancy, glaucoma, heart disease, allergy to drug class)
- SBP \>160
- DBP \> 90
- HR \>100
- Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
- Prisoner
- Intubated
- Unable take PO meds
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2023
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04332211
Start Date
May 1 2021
End Date
July 12 2023
Last Update
January 8 2025
Active Locations (1)
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1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201