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Phase 4 N=81 Randomized Quadruple-blind Prevention

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

Barotrauma;Ear

Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression — 8; 11 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Hyperbaric Oxygen Therapy (Procedure); Pseudoephedrine 60 MG (Drug); Placebo oral tablet (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Maryland, Baltimore
Primary completion
Jul 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Requirement of Oxymetalozine Rescue for Ear Pain During Hyperbaric Therapy Compression
8; 11
SECONDARY
Middle Ear Barotrauma Documentation Based on Otoscopy
6; 11
SECONDARY
Patient Description of Ear Pain
5; 12

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 commonly associated complication of HBOT is middle ear barotrauma (MEB) which occurs when the eustachian tube does not allow air to enter the middle ear space to equalize the pressure between the ambient environment and the inner ear. Patients experiencing MEB usually feel pressure or pain in their ear(s). The spectrum of symptoms ranges from sensation of ear fullness and muffled hearing to severe pain, vertigo and tympanic membrane rupture. The incidence of MEB, depending on the definition used is between 2-45%. The severe discomfort associated with MEB sometimes causes HBOT to be postponed or abandoned. Last year 27/991 treatments at our Center for Hyperbaric and Dive Medicine were aborted due to MEB. Currently there is no objective criteria for predicting which patients will experience these complications, nor is there consensus on effective prevention measures. At our facility, oxymetazoline, a topical nasal decongestant, is the standard rescue medication administered for patients that have symptoms of MEB during HBOT. This is despite two negative studies showing that this medication does not work any better than placebo. Other studies involving scuba divers and airplane travelers showed that oral pseudoephedrine is effective in decreasing MEB. However, the use of pseudoephedrine for patients undergoing HBOT has not been studied. The investigators plan to perform a randomized double blind placebo control trial to determine if pseudoephedrine is effective in decreasing the rate of MEB during HBOT.

Eligibility Criteria

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

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04332211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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