Pseudoephedrine and Air Travel–Associated Ear Pain in Children

Background  Young children often appear bothered by ear pain during ascent and descent while traveling on commercial airplanes. While pseudoephedrine hydrochloride is effective in decreasing the risk for earache in adults with recurrent air travel–associated ear pain, such use in children has not been studied.

Objective  To assess the efficacy and side effects of prophylactic pseudoephedrine in children traveling by air.

Design  A placebo-controlled, double-blind clinical trial.

Subjects and Methods  Children aged 6 months to 6 years were included in this study. Pseudoephedrine hydrochloride (1 mg/kg body weight) or placebo was administered 30 to 60 minutes prior to departure on commercial air flights. Caregivers noted historical details and the degree of apparent ear pain, drowsiness, and excitability with ascent and descent.

Results  Ninety-one flights involving 50 children were studied, with ear pain being reported in 13 (14%) of flights. Ear pain was not associated with a history of air travel–associated ear pain, recent ear infection, or recent upper airway symptoms. Pseudoephedrine use was not associated with a decrease in ear pain during either ascent (4% with pseudoephedrine vs 5% with placebo; P ≈ 1.00) or descent (12% with pseudoephedrine vs 13% with placebo;P ≈ 1.00). Pseudoephedrine use was, however, linked to drowsiness at takeoff (60% with pseudoephedrine vs 27% with placebo;P =.003) but not at landing (P =.39). Treatment was not associated with excitability at takeoff (P =.09) or landing (P≈1.00).

Conclusions  Ear pain is not uncommon in children traveling by commercial aircraft. The predeparture use of pseudoephedrine does not decrease the risk for in-flight ear pain in children but is associated with drowsiness.

AEROTITIS MEDIA, or aviation otitis, refers to an acute or chronic inflammation of the middle ear resulting from a failure to equilibrate tympanic cavity and atmospheric pressures secondary to eustachian tube obstruction. It is a common concern of parents planning airplane travel with their children. Preschool-aged children in particular often appear to be bothered by ear pain during both ascent and descent of commercial air travel. Although frequently confronted with this issue, pediatricians have little data on which to base advice and recommendations.

Common suggestions to prevent or alleviate such ear pain include chewing, yawning, and swallowing during ascent and descent, or using a warm, wet towel over the external ear to decrease "ambient" pressure during descent. Some physicians also advocate the administration of oral or nasal decongestants and/or antihistamines prior to takeoff.^1-3 These suggestions, however, are based on anecdotal evidence only and remain unsupported by scientific data.

Pseudoephedrine hydrochloride, a commonly used over-the-counter decongestant, is considered by many to be a valuable agent in relieving otic or eustachian tube congestion and/or obstruction. In a recent study of adults with a history of recurrent ear pain associated with air travel, the administration of oral pseudoephedrine 30 minutes before flight departure significantly reduced the occurrence of ear pain during the flight.⁴ A similar study demonstrated that oral pseudoephedrine was beneficial for the prevention of barotrauma in scuba divers.⁵ While there is a desire and need for a similar study in children, as of yet none has been reported.⁶

To evaluate the efficacy of pseudoephedrine for the prophylaxis of ear discomfort during air travel, we conducted a randomized, placebo-controlled, double-blind clinical trial with the following hypotheses: (1) oral pseudoephedrine decreases the incidence of air travel–associated ear pain in young children, (2) children at "high risk" for in-flight ear pain due to recent or concurrent upper respiratory tract infection symptoms will benefit more from oral pseudoephedrine prophylaxis than those not considered "high risk," and (3) prophylactic pseudoephedrine does not cause significant side effects.

Participants for this study were recruited by announcements posted in university student housing, a university medical center, pediatricians' offices, and day care centers, as well as through a travel agency. The subject population consisted of children aged 6 months to 6 years. Patients taking antihistamines and/or decongestants within 24 hours prior to air travel were excluded from the subject group. All conditions and procedures of the investigation were approved by the institutional review board at the University of Utah, Salt Lake City.

After expressing interest in the study, subjects and parents planning commercial air travel met with an investigator and were given a formal explanation of the study. Signed parental consent was obtained, and the subjects were given 2 randomly assigned treatment syringes (filled with placebo or pseudoephedrine) and 2 business reply questionnaire postcards (for the outbound and inbound flights). The syringes were identical in appearance and identified only by a randomly assigned sequential number. The identification key was kept by the pharmacist and was not revealed to the investigators until the time of data analysis. The pseudoephedrine hydrochloride dose was adjusted for the subject's weight (1 mg/kg, using a 6-mg/mL syrup). The oral dose from one treatment syringe was administered 30 to 60 minutes prior to departure from Salt Lake City and the other prior to takeoff for the return flight to Salt Lake City.

Questionnaires consisted of 4 yes/no questions regarding history of air travel–associated ear pain, ear infection in the past 2 weeks, cold or runny nose in the past 2 weeks, and runny nose or earache in the 24 hours prior to flight. In addition, apparent ear pain, drowsiness, and excitability during ascent and descent were ranked according to parents' subjective observations on a 4-point scale from none to severe. Specific instructions regarding concomitant activities (drinking, eating, yawning, chewing gum, sleeping) were not given, nor was the subjects' participation in such recorded. These business reply postcards were completed on arrival at the subject's destination and again on return to Salt Lake City.

Children with a history of prior ear pain during air travel or who were currently symptomatic for an upper respiratory tract infection were postulated to be at a higher risk for ear pain during the flight, making up the earlier-mentioned "high-risk" group. The Fisher exact test was used to compare categorical data. All tests were 2-tailed andP values less than .05 were considered significant. Data analyses were performed using Stata statistical software, version 5.0 (Stata Corporation, College Station, Tex).

Fifty children were recruited for this clinical trial. From these participants, there were 91 flights eligible for study, varying in duration from approximately 1 to 4 hours. The remaining 9 questionnaires (9%) were withdrawn due to instances in which the treatment was not given or was administered unsuccessfully. Three questionnaires were returned with information regarding ascent only. Children experienced ear pain in 14% of eligible flights (13/91). Of those who reported ear discomfort, 31% (4/13) experienced it during takeoff, or ascent, compared with 85% (11/13) who suffered from ear pain during landing, or descent. The possibility of a specific association between ear pain and altitude at takeoff and landing was not explored.

The use of prophylactic pseudoephedrine was not associated with a decrease in the incidence of ear pain during either ascent or descent. On ascent, 4% (2/50) of the pseudoephedrine group experienced ear pain compared with 5% (2/41) of the placebo group (risk difference, 1%; 95% confidence interval [CI], 9% to −8%; P≈1.00) On descent, pseudoephedrine use was associated with the incidence of ear pain at the rate of 12% (6/49) compared with 13% (5/39) with placebo (risk difference, 1%; 95% CI, 15% to −13%;P≈1.00).

The subgroup considered high risk because of a reported history predisposing them to in-flight ear pain, represented 65 (71%) of the 91 flights. These children were divided equally between the treatment and control groups (52% treatment, 48% control). When the data were reanalyzed within this subgroup, there remained no statistically significant difference between groups. On ascent, 3% (1/34) of the pseudoephedrine group experienced ear pain compared with 6% (2/31) of the placebo group (risk difference, 3%; 95% CI, 14% to −7%; P =.60). On descent, pseudoephedrine use was associated with the incidence of ear pain at the rate of 18% (6/33) compared with 10% (3/29) with placebo (risk difference, 8%; 95% CI, 25% to −9%; P =.48).

Finally, the association of prophylactic oral pseudoephedrine use with the incidence of side effects was analyzed. The rate of reported drowsiness during ascent was 60% (30/50) of the pseudoephedrine group compared with 27% (11/ 41) of the placebo group (risk difference, 33%; 95% CI, 14% to 52%; P =.003). The incidence of drowsiness at the time of landing was similar in both the treatment and placebo groups (47% vs 36%; risk difference, 11%; 95% CI, 32% to −9%; P =.39). Takeoff excitability approached, but did not reach, a statistically significant difference with an incidence of 16% (8/50) in the treatment group vs 32% (13/ 41) of the control group (risk difference, 16%; 95% CI, 33% to −2%;P =.09). Excitability at landing was reported in 16% (8/50) of the treatment group vs 18% (7/39) of the placebo group (risk difference, 2%; 95% CI, 18% to −14%; P≈1.00).

To our knowledge, this is the first placebo-controlled study evaluating the use of pseudoephedrine for the prevention of air travel–related ear discomfort in children. Oral pseudoephedrine administered 30 to 60 minutes prior to air travel did not significantly affect the incidence of ear pain in children aged 6 months to 6 years. There was, however, a significant increase in the incidence of drowsiness in those receiving pseudoephedrine.

Air travel–related ear pain results from the lack of pressure equalization between the external environment and the small volumes of air that exist within the inner ear. With the decrease in atmospheric pressure as an aircraft ascends, the gas in the middle ear expands in accordance with Boyle's law, causing ear discomfort or pain. Likewise, the gas in the middle ear contracts as the aircraft descends and atmospheric pressure increases, again resulting in aerotitis media. Intentional manipulations such as chewing, swallowing, yawning, or insufflation by the Valsalva maneuver are oftentimes required to open the tubal lumen and allow pressure equilibration. Children may be more prone to aerotitis media due in part to the anatomic differences of their eustachian tubes as well as their increased frequency of viral upper respiratory tract infections. A child's eustachian tube is narrower and more horizontal and its opening, the torus tubarius, is likely to have numerous lymphoid follicles surrounding it. Adenoids may also fill the nasopharynx, mechanically blocking the eustachian tube orifice or acting as a focus of infection that may contribute to edema of the eustachian tube mucosa and increased tube dysfunction.⁷

It has been proposed that sympathomimetic agents may be effective in the prevention of middle ear barotrauma in adults based on their effect on α-adrenergic receptors in the respiratory tract mucosa, resulting in vasoconstriction and subsequent reduction of tissue swelling, edema, and congestion.⁵ There are no data, however, to support the use of decongestants or common cold remedies in preschool-aged children.⁸ The present study found oral pseudoephedrine to be ineffective in preventing air travel–related ear pain in children. These findings are consistent with and extend the findings of previous studies showing no clinically significant improvement in upper respiratory tract symptoms⁹ or abnormal middle ear pressures¹⁰ with the respective use of an antihistamine-decongestant combination⁹ or topical decongestant¹⁰ in infants with common colds. Although the precise reason for this ineffectiveness of decongestants in young children is not known, it has been demonstrated that pseudoephedrine is eliminated much more rapidly in children, with a mean terminal elimination half-life of 3.1 hours vs the 5 to 8 hours found in adults.¹¹ The clearance rates have likewise been found to be significantly higher in children than in adults.¹¹ Another possible contributor to the difference between this study's findings and those of a similar adult trial may be that the 1-mg/kg dose of pseudoephedrine is a smaller dose per kilogram than the 120 mg administered to the adult subjects.⁴

This study also found a higher incidence of drowsiness, a known side effect of pseudoephedrine use in some children, in the treatment group vs the placebo group. One might argue that this apparently benign side effect may be beneficial for young children who can be frightened by the transition from ground to air travel. The question as to the appropriateness of medicating a child for such a purpose was not addressed by this study. However, if one does conclude that the side effect of drowsiness is indeed beneficial, other agents (such as diphenhydramine) may be both more consistent and effective in achieving the desired results.

There are some limitations that must be taken into consideration when evaluating these data. While the 1% difference observed between treatment and control groups is not thought to be clinically significant, a larger number of subjects would be required to comfortably exclude the possibility of larger differences between study groups. In addition, the nature of this study required reliance on subjective observations by the subjects' parents. However, there is no reason to expect that observer bias would significantly affect the results in this double-blind, placebo-controlled study.

In conclusion, despite its reported effectiveness in adults, oral pseudoephedrine does not appear to decrease the incidence of ear pain in children traveling by air. Likewise, among "high-risk" children thought to potentially benefit most from decongestant prophylaxis during air travel, there is no decrease in the incidence of ear pain with pseudoephedrine use. Oral pseudoephedrine ingestion is also associated with a significant side effect, early flight drowsiness, compared with placebo. The results of this study do not support the practice of administering oral pseudoephedrine to prevent air travel–associated ear pain in children.

Accepted for publication September 15, 1998.

Presented in part at the Western Regional Meeting of the Ambulatory Pediatric Association, Carmel-by-the-Sea, Calif, February 9, 1997, and at the Fifth International Conference on Travel Medicine, Geneva, Switzerland, March 26, 1997.

The authors gratefully acknowledge Nathan Kuppermann, MD, for his critical review of the manuscript and his helpful guidance in the statistical analysis.

Reprints: Philip R. Fischer, MD, Department of Pediatric and Adolescent Medicine, Mayo Clinic, 200 First St SW, Rochester, MN 55905.

Editor's Note: Give the child something to stimulate swallowing on ascent and descent, let nature take care of the problem, and throw the medication out the door—preferably before you take off.—Catherine D. DeAngelis, MD