Barotrauma in Hyperbaric Oxygen Therapy
ConditionBarotrauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Muir Health
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pseudoephedrine Pill
DrugOne-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
Placebo
DrugOne time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: PseudoephedrineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
45-60 minutesSecondary outcomes
1
Incidence of completed compression
Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.
Time frame
1 minuteSponsors and contacts
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Source ClinicalTrials.gov