Pseudoephedrine prophylaxis does not prevent middle ear barotrauma in hyperbaric oxygen therapy

Area of Science:

• Baromedical research
• Otolaryngology
• Clinical pharmacology

Background:

• Middle ear barotrauma (MEB) is a frequent complication of hyperbaric oxygen (HBO₂) therapy, potentially causing pain and treatment interruption.
• Previous research suggests pseudoephedrine may reduce MEB in divers and air travelers.
• The efficacy of pseudoephedrine for MEB prevention in HBO₂ patients remains unestablished.

Purpose of the Study:

• To evaluate the effectiveness of pseudoephedrine in preventing middle ear barotrauma (MEB) in patients receiving their initial hyperbaric oxygen (HBO₂) treatment.
• To assess the impact of pseudoephedrine on ear pain, tympanic membrane integrity, and the need for rescue medication.

Main Methods:

• A randomized, double-blind, placebo-controlled trial was conducted.
• Participants received either pseudoephedrine or a placebo before their first multiplace HBO₂ treatment.
• Outcomes measured included ear pain, tympanic membrane injury, and use of rescue medication.

Main Results:

• No statistically significant difference was observed between the pseudoephedrine and placebo groups regarding ear pain.
• Tympanic membrane injury rates and the need for rescue medication to equalize ear pressure did not differ significantly between groups.
• Pseudoephedrine prophylaxis administered 45 minutes to two hours prior to treatment did not mitigate MEB or delays.

Conclusions:

• Pseudoephedrine is not effective in preventing middle ear barotrauma (MEB) in patients undergoing hyperbaric oxygen (HBO₂) treatment.
• The findings do not support the prophylactic use of pseudoephedrine to mitigate MEB or treatment delays in this patient population.
• Further research may be needed to explore alternative prophylactic strategies for MEB in hyperbaric medicine.