Download as pdf or txt
Download as pdf or txt
You are on page 1of 10

Ear, nose, and throat disorders

..................................................

Middle-ear pain and trauma during air travel


Search date July 2014
Tony Wright

ABSTRACT
INTRODUCTION: Changes in air pressure during flying can cause ear-drum pain and perforation, vertigo, and hearing loss. It has been
estimated that 10% of adults and 22% of children might have changes to the ear drum after a flight, although perforation is rare. Symptoms
usually resolve spontaneously. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical
question: What are the effects of interventions to prevent middle-ear pain during air travel? We searched: Medline, Embase, The Cochrane
Library and other important databases up to July 2014 (Clinical Evidence reviews are updated periodically; please check our website for the
most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration
(FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found three studies that met our inclusion
criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we
present information relating to the effectiveness and safety of the following interventions: nasal balloon inflation, nasal decongestants (topical),
and oral pseudoephedrine.

QUESTIONS
What are the effects of interventions to prevent middle-ear pain during air travel?. . . . . . . . . . . . . . . . . . . . . . . 3

INTERVENTIONS
PREVENTING MIDDLE-EAR PAIN DURING AIR Pseudoephedrine (oral) in children . . . . . . . . . . . . . . 8
TRAVEL
Likely to be beneficial Footnote

Nasal balloon inflation* . . . . . . . . . . . . . . . . . . . . . . . 3 *Nasal balloon inflation: categorisation based on non-


RCT evidence
Pseudoephedrine (oral) in adults . . . . . . . . . . . . . . . 5

Unknown effectiveness
Nasal decongestants (topical) . . . . . . . . . . . . . . . . . 3

Key points

• Changes in air pressure during flying can cause ear-drum pain and perforation, vertigo, and hearing loss.
It has been estimated that 10% of adults and 22% of children might have changes to the ear drum after a flight,
although perforation is rare.
Symptoms usually resolve spontaneously.
• We did not find any RCT evidence assessing nasal balloon inflation, but non-RCT evidence suggests that it may
prevent symptoms of barotitis in people during air travel compared with controls.
• Oral pseudoephedrine compared with placebo may prevent symptoms in adults with previous ear pain during
flights.
We don't know whether oral pseudoephedrine is also beneficial in children, but it may cause drowsiness.
• We don't know whether topical nasal decongestants can prevent symptoms of barotrauma compared with placebo.

Clinical context

DEFINITION The normal middle ear and mastoid is filled with air at atmospheric pressure, and the tympanic
membrane (eardrum) is most efficient at absorbing sound when the air pressures are the same
both sides (i.e., the membrane is not stretched). The air in the middle ear comes from the nasophar-
ynx by way of the Eustachian tube. This is about 36 mm long, with the outer (ear) third having a
rigid bony wall tapering to a diameter of less than 1 mm, where it meets the inner (nasopharyngeal)
two-thirds, with walls made of cartilage, soft tissue, and muscles. The tube is lined with respiratory
epithelium containing goblet cells and mucus glands, and has a carpet of ciliated cells along its
floor. The Eustachian tube is usually closed, but may open on swallowing and usually on yawning
to allow air to move from the nasopharynx to the middle ear and mastoid to replace the oxygen
that has been absorbed by the respiratory mucosa. During ascent in an aeroplane flight, the external
pressure drops and it is relatively easy for air to escape from the middle ear down its pressure
gradient into the nasopharynx. As the plane starts to descend, the external pressure increases and
the Eustachian tube has to open to allow the relatively low middle ear pressures to equalise. This
is not so easy, as the increasing external pressures tend to hamper the opening of the Eustachian
tube. The increasing external pressure causes the eardrum to be stretched inwards, but the strength
and elastic properties of the normal eardrum may be enough to physically withstand this pressure
difference — although pain develops. On landing, the pain gradually resolves but observation of
© BMJ Publishing Group Ltd 2015. All rights reserved. . . . . . . . . . . . . . . . . . . . . . 1 . . . . . . . . . . . . . . . . . . . . . Clinical Evidence 2015;01:501
Ear, nose, and throat disorders
Middle-ear pain and trauma during air travel
the ear usually shows dilated blood vessels running down the handle of the malleus and sometimes
slight bruising of the front parts of the membrane.These are common, transient changes that resolve
completely and do not cause damage. This is barotitis. Occasionally, there comes a point called
the 'critical closing pressure', when the tube cannot open and the pressure differential in the middle
ear increases to the extent that changes occur. One such point may occur if there is an outpouring
of fluid into the middle ear from the mucosa lining it. The fluid is an exudate or blood or both. Thus,
the middle ear fills to a greater or lesser extent with fluid and the pressure on the membrane is re-
lieved (Boyle's Law: P1V1 = P2V2). The downside of this is that the individual’s hearing becomes
significantly reduced, and this may persist for 1 month or more.The alternative is that, in a membrane
with a healed perforation, the thin scar gives way and a new perforation develops, thereby instantly
overcoming the pressure differential but again leaving some hearing loss and possibly an additional
blood-stained discharge. These two complications are called barotrauma and are uncommon given
the many plane flights each year. Both of these problems can result in a balance problem with
unsteadiness. However, vertigo, with a prolonged sense of unreal movement (which is usually rotary),
is very rare and suggests some disruption of the inner ear with a possible perilymph leak.

INCIDENCE/ The prevalence of symptoms depends on the altitude, type of aircraft, and characteristics of the
PREVALENCE passengers. One point prevalence study found that, in commercial passengers, 20% of adult and
40% of child passengers had negative pressure in the middle ear after flight, and that 10% of adults
[1]
and 22% of children had otoscopic evidence of changes to the ear drum. We found no data on
the incidence of perforation, which seems to be extremely rare in commercial passengers.

AETIOLOGY/ The factors predisposing to barotrauma include the quality of cabin pressurisation and the speed
RISK FACTORS of descent (short haul flights are worse in general), the individual’s anatomy and Eustachian tube
function, the state of the respiratory mucosa at the time of the flight (with inflammation from colds,
allergies, or sensitivities), and being awake or asleep (asleep is worse because the individual
swallows much less). Because of this huge variability, good studies are very hard to perform.

[2]
PROGNOSIS Experience in military aviation shows that most perforations will heal spontaneously in adults.

AIMS OF To prevent middle-ear pain and trauma during air travel, with minimal adverse effects.
INTERVENTION
OUTCOMES Barotrauma (includes incidence and severity of pain and hearing loss, and incidence of perforation
of ear drum); adverse effects.

METHODS Clinical Evidence search and appraisal July 2014. The following databases were used to identify
studies for this systematic review: Medline 1966 to July 2014, Embase 1980 to July 2014, and The
Cochrane Database of Systematic Reviews 2014, issue 6 (1966 to date of issue). Additional
searches were carried out in the Database of Abstracts of Reviews of Effects (DARE) and the
Health Technology Assessment (HTA) database. We also searched for retractions of studies in-
cluded in the review. Titles and abstracts identified by the initial search, run by an information
specialist, were first assessed against predefined criteria by an evidence scanner. Full texts for
potentially relevant studies were then assessed against predefined criteria by an evidence analyst.
Studies selected for inclusion were discussed with an expert contributor. All data relevant to the
review were then extracted by an evidence analyst. Study design criteria for inclusion in this review
were published RCTs and systematic reviews of RCTs in the English language, at least single-
blinded, and containing more than 20 individuals (10 in each arm), of whom more than 80% were
followed up. There was no minimum length of follow-up. We excluded all studies described as
'open', 'open label', or not blinded unless blinding was impossible. We included RCTs and system-
atic reviews of RCTs where harms of an included intervention were assessed, applying the same
study design criteria for inclusion as we did for benefits. In addition, we use a regular surveillance
protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are
added to the reviews as required. To aid readability of the numerical data in our reviews, we round
many percentages to the nearest whole number. Readers should be aware of this when relating
percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have
performed a GRADE evaluation of the quality of evidence for interventions included in this review
(see table, p 10 ). The categorisation of the quality of the evidence (high, moderate, low, or very
low) reflects the quality of evidence available for our chosen outcomes in our defined populations
of interest. These categorisations are not necessarily a reflection of the overall methodological
quality of any individual study, because the Clinical Evidence population and outcome of choice
may represent only a small subset of the total outcomes reported, and population included, in any
individual trial. For further details of how we perform the GRADE evaluation and the scoring system
we use, please see our website (www.clinicalevidence.com).

© BMJ Publishing Group Ltd 2015. All rights reserved. ........................................................... 2


Ear, nose, and throat disorders
Middle-ear pain and trauma during air travel
QUESTION What are the effects of interventions to prevent middle-ear pain during air travel?

OPTION NASAL BALLOON INFLATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• For GRADE evaluation of interventions for Middle-ear pain and trauma during air travel, see table, p 10 .
• We found no RCT evidence assessing nasal balloon inflation, but non-RCT evidence suggests that it may prevent
symptoms of barotitis in people during air travel compared with controls.

Benefits and harms


Nasal balloon inflation versus placebo/no treatment:
We found no direct information from systematic reviews or RCTs comparing nasal balloon inflation during flight versus
placebo or no nasal balloon inflation (see Comment section, p 3 ).

-
-
-
-
Comment: We found one prospective controlled clinical trial (120 people), which compared nasal balloon in-
[3]
flation during descent with control groups of no nasal balloon inflation. The trial found a significant
difference in otoscopic signs of barotitis between the groups: 2/36 (6%) with nasal balloon inflation;
10/69 (15%) with control (P <0.05). The trial was also of sufficient sample size and power to detect
the efficacy of nasal balloon inflation in reducing the symptoms of barotrauma during flight among
adults. It was reported that 105 people who had negative middle-ear pressure after the flight per-
formed a Valsalva manoeuvre (forceful blowing of air while keeping the mouth and nose closed),
after which 48/105 (46%) had equalised their middle-ear pressure. The remaining 57 underwent
nasal balloon inflation. The study found that 36/52 (69%) were able to equalise their middle-ear
pressure after nasal balloon inflation. One of the main limitations of the trial is that the intervention
and control groups took different flights, which may lead to bias.

Clinical guide
In the nasal balloon study, the authors looked at the efficacy of reducing the symptoms and signs
of barotitis rather than barotrauma. The study looked at middle-ear pressures and normalisation
rather than middle-ear effusions and perforations.

There were no adverse outcomes, and this would seem a reasonable way of trying to reduce the
development of symptoms in those prone to ear pain and discomfort. The logic of applying a me-
chanical solution to assisting the re-ventilation of the middle ear is difficult to refute, provided that
the balloon ventilation is started early enough.

OPTION NASAL DECONGESTANTS (TOPICAL). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• For GRADE evaluation of interventions for Middle-ear pain and trauma during air travel, see table, p 10 .
• We don't know whether topical nasal decongestants can prevent symptoms of barotrauma compared with
placebo.

Benefits and harms


Topical nasal decongestants versus placebo:
We found no systematic review. We found one RCT in adult passengers with a history of ear pain during air travel.
[4]

-
Barotrauma
Topical nasal decongestants compared with placebo Nasal decongestant (oxymetazoline nasal spray) seems no
more effective than placebo at preventing symptoms of barotrauma in adults with a history of ear pain during air
travel (moderate-quality evidence).

© BMJ Publishing Group Ltd 2015. All rights reserved. ........................................................... 3


Ear, nose, and throat disorders
Middle-ear pain and trauma during air travel
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Barotrauma
[4]
150 adults with a Proportion of people with P = 0.695
history of ear pain symptoms of barotrauma (ear
RCT
during air travel pain, blockage, hearing loss,
3-armed dizziness/vertigo, and tinnitus;
trial assessed by post-flight ques-
tionnaire)
27/42 (64%) with oxymetazoline
Not significant
nasal spray
29/41 (71%) with placebo
Oxymetazoline was given at least
30 minutes before flight
The remaining arm evaluated oral
pseudoephedrine

-
Adverse effects

-
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Nasal irritation
[4]
150 adults with a Nasal irritation Significance not assessed
history of ear pain
RCT 6/42 (14%) with oxymetazoline
during air travel
nasal spray
3-armed
trial 0/41 (0%) with placebo
Oxymetazoline was given at least
30 minutes before flight
The remaining arm evaluated oral
pseudoephedrine

Drowsiness
[4]
150 adults with a Drowsiness Significance not assessed
history of ear pain
RCT 1/42 (2%) with oxymetazoline
during air travel
nasal spray
3-armed
trial 2/41 (5%) with placebo
Oxymetazoline was given at least
30 minutes before flight
The remaining arm evaluated oral
pseudoephedrine

Dry mouth
[4]
150 adults with a Dry mouth Significance not assessed
history of ear pain
RCT 1/42 (2%) with oxymetazoline
during air travel
nasal spray
3-armed
trial 1/41 (2%) with placebo
Oxymetazoline was given at least
30 minutes before flight
The remaining arm evaluated oral
pseudoephedrine

Gastrointestinal symptoms
[4]
150 adults with a Stomach upset Significance not assessed
history of ear pain
RCT 1/42 (2%) with oxymetazoline
during air travel
nasal spray
3-armed
trial 0/41 (0%) with placebo

© BMJ Publishing Group Ltd 2015. All rights reserved. ........................................................... 4


Ear, nose, and throat disorders
Middle-ear pain and trauma during air travel
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Oxymetazoline was given at least
30 minutes before flight
The remaining arm evaluated oral
pseudoephedrine

Headache
[4]
150 adults with a Headache Significance not assessed
history of ear pain
RCT 1/42 (2%) with oxymetazoline
during air travel
nasal spray
3-armed
trial 1/42 (2%) with placebo
Oxymetazoline was given at least
30 minutes before flight
The remaining arm evaluated oral
pseudoephedrine

-
-
-
Further information on studies
[4]
The RCT may have been too small to detect an effect of topical nasal decongestants.

-
-
Comment: Clinical guide
It is not to be expected that topical nasal decongestants would have any significant impact on the
[4]
function of the Eustachian tube, and this study confirms that lack of effect. While they may help
to clear the nose and possibly reduce pain from the sinuses during pressure changes in flight, there
is no evidence that they help to reduce pain from the ears.

OPTION PSEUDOEPHEDRINE (ORAL) IN ADULTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• For GRADE evaluation of interventions for Middle-ear pain and trauma during air travel, see table, p 10 .
• Oral pseudoephedrine compared with placebo may prevent symptoms in adults with previous ear pain during
flights.

Benefits and harms


Oral pseudoephedrine versus placebo in adults:
We found no systematic review. We found two RCTs in adult passengers with a history of ear pain during air travel.
[4] [5]

-
Barotrauma
Oral pseudoephedrine compared with placebo in adults Oral pseudoephedrine seems more effective than placebo
at reducing the symptoms of barotrauma during air travel, such as ear pain and hearing loss, in adults with a history
of ear pain (moderate-quality evidence).

Ref Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Symptoms of barotrauma
[4]
150 adults with a Proportion of people with RR 0.48
history of ear pain symptoms of barotrauma (ear
RCT 95% CI 0.29 to 0.67
during air travel pain, blockage, hearing loss,
3-armed dizziness/vertigo, and tinnitus; oral pseu-
People with acute doephedrine
trial assessed by post-flight ques-
or chronic ear
tionnaire)
problems were ex-
cluded

© BMJ Publishing Group Ltd 2015. All rights reserved. ........................................................... 5


Ear, nose, and throat disorders
Middle-ear pain and trauma during air travel
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
14/41 (34%) with oral pseu-
doephedrine
29/41 (71%) with placebo
Pseudoephedrine was given at
least 30 minutes before flying
The remaining arm evaluated
oxymetazoline nasal spray

[5]
190 adults Proportion of people reporting P = 0.007
ear pain (assessed by post-
RCT People with acute
flight questionnaire)
or chronic ear
problems were ex- 25/96 (26%) with oral pseu- oral pseu-
cluded doephedrine doephedrine
43/94 (46%) with placebo
Pseudoephedrine was given at
least 30 minutes before flying

[5]
190 adults Proportion of people reporting P = 0.006
hearing loss (assessed by
RCT People with acute
post-flight questionnaire)
or chronic ear
problems were ex- 20/96 (21%) with oral pseu- oral pseu-
cluded doephedrine doephedrine
38/94 (40%) with placebo
Pseudoephedrine was given at
least 30 minutes before flying

-
Adverse effects

-
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Drowsiness
[4]
150 adults with a Drowsiness Significance not assessed
history of ear pain
RCT 4/41 (10%) with oral pseu-
during air travel
doephedrine
3-armed
People with acute
trial 2/41 (5%) with placebo
or chronic ear
problems were ex- Pseudoephedrine was given at
cluded least 30 minutes before flying
The remaining arm evaluated
oxymetazoline nasal spray

[5]
190 adults Drowsiness Significance not assessed
RCT People with acute 7/96 (7%) with oral pseu-
or chronic ear doephedrine
problems were ex-
2/94 (2%) with placebo
cluded
Pseudoephedrine was given at
least 30 minutes before flying

Dry mouth and nausea


[4]
150 adults with a Dry mouth Significance not assessed
history of ear pain
RCT 4/41 (10%) with oral pseu-
during air travel
doephedrine
3-armed
People with acute
trial 1/41 (2%) with placebo
or chronic ear
problems were ex- Pseudoephedrine was given at
cluded least 30 minutes before flying
The remaining arm evaluated
oxymetazoline nasal spray

© BMJ Publishing Group Ltd 2015. All rights reserved. ........................................................... 6


Ear, nose, and throat disorders
Middle-ear pain and trauma during air travel
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
[5]
190 adults Dry mouth and nausea Significance not assessed
RCT People with acute 4.2% with oral pseudoephedrine
or chronic ear
4.3% with placebo
problems were ex-
cluded Absolute numbers not reported
Pseudoephedrine was given at
least 30 minutes before flying

Nasal irritation
[4]
150 adults with a Nasal irritation Significance not assessed
history of ear pain
RCT 1/41 (2%) with oral pseu-
during air travel
doephedrine
3-armed
People with acute
trial 0/41 (0%) with placebo
or chronic ear
problems were ex- Pseudoephedrine was given at
cluded least 30 minutes before flying
The remaining arm evaluated
oxymetazoline nasal spray

Gastrointestinal symptoms
[4]
150 adults with a Stomach upset Significance not assessed
history of ear pain
RCT 1/41 (2%) with oral pseu-
during air travel
doephedrine
3-armed
People with acute
trial 0/41 (0%) with placebo
or chronic ear
problems were ex- Pseudoephedrine was given at
cluded least 30 minutes before flying
The remaining arm evaluated
oxymetazoline nasal spray

Headache
[4]
150 adults with a Headache Significance not assessed
history of ear pain
RCT 0/41 (0%) with oral pseu-
during air travel
doephedrine
3-armed
People with acute
trial 1/41 (2%) with placebo
or chronic ear
problems were ex- Pseudoephedrine was given at
cluded least 30 minutes before flying
The remaining arm evaluated
oxymetazoline nasal spray

-
-
-
-
Comment: Clinical guide
There is a statistical benefit from oral pseudoephedrine, although it is difficult to tell if this is of
practical use. The treatment was given to adults with a history of ear pain during flight and halved
the number of people with symptoms in both reported studies. The most important side effect as
far as barotitis was concerned was drowsiness, as this could reduce the frequency of swallowing
and make the chances of developing ear symptoms greater.

Using a systemic decongestant to reduce the chance of barotitis is consistent with the mechanism
of the problem, and the improvement with oral pseudoephedrine makes it worth recommending
provided that the person does not have hypertension or coronary artery disease. What people with
colds frequently ask is whether they should fly and if there is anything they can take to help. These
[4] [5]
trials excluded patients with acute ear problems, but if they have to travel, oral pseu-
doephedrine may be helpful in some people.

© BMJ Publishing Group Ltd 2015. All rights reserved. ........................................................... 7


Ear, nose, and throat disorders
Middle-ear pain and trauma during air travel
OPTION PSEUDOEPHEDRINE (ORAL) IN CHILDREN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• For GRADE evaluation of interventions for Middle-ear pain and trauma during air travel, see table, p 10 .
• We don't know whether oral pseudoephedrine is beneficial in children, but it may cause drowsiness.

Benefits and harms


Oral pseudoephedrine versus placebo in children:
[6]
We found no systematic review. We found one RCT in children.

-
Barotrauma
Oral pseudoephedrine compared with placebo in children Oral pseudoephedrine may be no more effective at pre-
venting ear pain at take-off or landing compared with placebo in children (low-quality evidence).

Ref Results and statistical Effect


(type) Population Outcome, Interventions analysis size Favours
Ear pain
[6]
50 children aged 6 Proportion of children report- P = 1.0
months to 6 years, ing ear pain , take off
RCT
total of 91 flights
2/50 (4%) with oral pseu-
assessed
doephedrine Not significant
2/41 (5%) with placebo
Denominator is number of flights
in analysis

[6]
50 children aged 6 Proportion of children report- P = 1.0
months to 6 years, ing ear pain , landing
RCT
total of 91 flights
6/49 (12%) with oral pseu-
assessed
doephedrine Not significant
5/39 (13%) with placebo
Denominator is number of flights
in analysis

-
Adverse effects

-
Ref Results and statistical Effect
(type) Population Outcome, Interventions analysis size Favours
Drowsiness
[6]
50 children aged 6 Proportion of children report- P = 0.003
months to 6 years, ing drowsiness , take off
RCT
total of 91 flights
30/50 (60%) with oral pseu-
assessed
doephedrine placebo
11/41 (27%) with placebo
Denominator is number of flights
in analysis

-
-
-
-
Comment: Clinical guide
Oral pseudoephedrine in children was not effective compared to placebo nor to its action in adults.
This may be because children have a much smaller mastoid volume, as other works have shown
[7]
that a small mastoid volume 'protects' against barotrauma. The study reported above included
[6]
'at-risk' children (i.e., those with colds), and the pseudoephedrine was not protective. The
downside was significant drowsiness, which may or may not be a benefit.

© BMJ Publishing Group Ltd 2015. All rights reserved. ........................................................... 8


Ear, nose, and throat disorders
Middle-ear pain and trauma during air travel
GLOSSARY
Barotitis Symptoms and signs that arise from air pressure changes across the eardrum. There can be a feeling of
blockage and fullness and even pain, with a reduction in the hearing and possibly tinnitus. The eardrum often has
dilated blood vessels appearing on the malleus handle and the adjacent ear canal skin, and there may even be some
bruising of the anterior parts of the membrane, but the middle ear remains air filled and the eardrum intact. These
effects are transient and usually resolve spontaneously.
Barotrauma Symptoms resulting from severe air pressure changes across the eardrum causing physical changes
to the eardrum and/or middle ear. There is increasing discomfort and pain (as per the original definition of 'trauma',
from the Greek meaning 'a wound'), with reduced hearing and possibly tinnitus. There may be unsteadiness and in
very rare cases even vertigo. The middle ear can fill with exudate or blood, and a weakened eardrum can perforate,
resulting in a blood-stained discharge.
Low-quality evidence Further research is very likely to have an important impact on our confidence in the estimate
of effect and is likely to change the estimate.
Moderate-quality evidence Further research is likely to have an important impact on our confidence in the estimate
of effect and may change the estimate.

SUBSTANTIVE CHANGES
Nasal balloon inflation Evidence re-evaluated. Categorisation changed from 'likely to be beneficial' to 'likely to be
beneficial based on non-RCT evidence'.
Nasal decongestants (topical) Evidence re-evaluated. Categorisation unchanged (unknown effectiveness).
Pseudoephedrine (oral) in adults Evidence re-evaluated. Categorisation unchanged (likely to be beneficial).
Pseudoephedrine (oral) in children Evidence re-evaluated. Categorisation unchanged (unknown effectiveness).

REFERENCES
1. Stangerup SE, Tjernström O, Klokker M, et al. Point prevalence of barotitis in 4. Jones JS, Sheffield W, White LJ, et al. A double-blind comparison between oral
children and adults after flight, and the effect of autoinflation. Aviat Space Environ pseudoephedrine and topical oxymetazoline in the prevention of barotrauma
Med 1998;69:45–49.[PubMed] during air travel. Am J Emerg Med 1998;16:262–264.[PubMed]
2. O'Reilly BJ. Otorhinolaryngology. In: Ernsting J, Nicholson AN, Rainford DJ, eds. 5. Csortan E, Jones J, Haan M, et al. Efficacy of pseudoephedrine for the prevention
Aviation medicine. 3rd ed. Oxford: Butterworth-Heinemann, 1999:319–336. of barotrauma during air travel. Ann Emerg Med 1994;23:1324–1327.[PubMed]
3. Stangerup SE, Klokker M, Vesterhauge S, et al. Point prevalence of barotitis and 6. Buchanan BJ, Hoagland J, Fischer PR. Pseudoephedrine and air travel-associ-
its prevention and treatment with nasal balloon inflation: a prospective, controlled ated ear pain in children. Arch Pediatr Adolesc Med 1999;153:466–468.[PubMed]
study. Otol Neurotol 2004;25:89–94.[PubMed] 7. Sadé J, Ar A, Fuchs C. Barotrauma vis-a-vis the "chronic otitis media syndrome":
two conditions with middle ear gas deficiency – is secretory otitis media a con-
traindication to air travel? Ann Otol Rhinol Laryngol 2003;112:230–235.[PubMed]

Tony Wright
Emeritus Professor of Otolaryngology
UCL Ear Institute
London
UK

Competing interests: TW declares that he has no competing interests.


We would like to acknowledge the previous contributors of this review, including Arin Basu and Simon Janvrin.

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a
judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and
harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices.
Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research
we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the
categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately
it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest
extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any
person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, inci-
dental or consequential, resulting from the application of the information in this publication.

© BMJ Publishing Group Ltd 2015. All rights reserved. ........................................................... 9


Ear, nose, and throat disorders
Middle-ear pain and trauma during air travel
GRADE Evaluation of interventions for Middle-ear pain and trauma during air travel.
-
Important out-
comes Barotrauma
Studies (Partici- Type of evi-
pants) Outcome Comparison dence Quality Consistency Directness Effect size GRADE Comment
What are the effects of interventions to prevent middle-ear pain during air travel?
[4]
1 (83) Barotrauma Topical nasal deconges- 4 –1 0 0 0 Moderate Quality point deducted for
tants versus placebo sparse data
[4] [5]
2 (272) Barotrauma Oral pseudoephedrine 4 –1 0 0 0 Moderate Quality point deducted for uncer-
versus placebo in adults tainty about assessment of out-
come
[6]
1 (91) Barotrauma Oral pseudoephedrine 4 –2 0 0 0 Low Quality points deducted for
versus placebo in chil- sparse data and for analysis of
dren a different measure than that
randomised (children ran-
domised, but analysis based on
number of flights)
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial
score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-
randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude
of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.

© BMJ Publishing Group Ltd 2015. All rights reserved. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

You might also like