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: September
2005