Brown
Pseudoephedrine reduced the incidence of middle ear barotrauma in novice divers.
Clinical bottom line: Administration of 60mg oral pseudoephedrine reduced the incidence of middle ear barotrauma in novice divers.
Citation: Brown M, Jones J, Krohmer J. Pseudoephedrine for the Prevention of Barotitis Media: A Controlled Clinical Trial in Underwater Divers. Annals of Emergency Medicine 1992;21(7):106-109. Lead author's name and fax: Michael Brown, MD, Department of Emergency Medicine, Grand Rapids, Michigan 49503
Three-part Clinical Question: Among first time divers, does the administration of oral pseudoephedrine, compared to placebo, reduce the incidence or severity of middle ear barotraumas? Search Terms: Hyperbaric oxygenation, Barotrauma, Otitis
The Study: Double-blind concealed randomised controlled trial with intention-to-treat. The Study Patients: Fit and healthy volunteers undergoing their first certification dive, aged between 18 and 35. Control group: (N = 56; 56 analysed): Oral placebo administered at least 30 minutes prior to undertaking standard open water dive training. Experimental group: (N = 60; 60 analysed): 60mg of oral pseudoephedrine administered as above.
The Evidence:
| Outcome | Time to Outcome | Placebo rate | Active rate | Relative risk reduction | Absolute risk reduction | NNT |
| ME Barotrauma | Immediate | 0.32 | 0.08 | 74% | 0.24 | 4 |
| 95%CI | 30%–100% | 0.1–0.38 | 3 - 10 | |||
| Teed score >0 | Immediate | 0.46 | 0.22 | 53% | 0.25 | 4 |
| 95% CI | 17%-89% | 0.08-0.41 | 2 to 13 |
Comments: 1. Well designed and reliable trial. 2. The pseudoephedrine dose is relatively high (2 tabs). 3. No data on later performance – e.g. second dive of the day. 4. Volunteers represent a young and healthy section of the population and results may not generalize to the general population (high dose of active drug), or even general diving population (lower prevalence of ME barotraumas). 5. Authors conclude that severity of injury is reduced, but there is no evidence to support this.
Appraised by: Mike Adams, Cardiff, UK, and Mike Bennett, POWH, Sydney. Thursday, 25 September 2003 Email: [Seyking@hotmail.com]
Kill or Update By: December 2021
