A new AAP clinical report recommends taking precautions with the dosing and administration technique of an over-the-counter (OTC) nasal decongestant used in surgery due to adverse events reported in children.
Oxymetazoline hydrochloride 0.05% is the active ingredient in OTC nasal spray decongestants, including Afrin. The product is approved for patients ages 6 years and older. It is used off-label during nasal intubation and ear, nose and throat (ENT) surgery to improve visualization of the airway and minimize intraoperative or postoperative bleeding. Cardiac and respiratory complications have occurred in children related to routine perioperative use of oxymetazoline.
To avoid excessive dosing, clinicians should use the spray bottle in an upright position with the child upright and follow label instructions for dosing.
The recommendation is highlighted in the clinical report Topical Nasal Decongestant Oxymetazoline: Safety Considerations for Perioperative Pediatric Use from the Section on Anesthesiology and Pain Medicine and Section on Otolaryngology-Head and Neck Surgery. It is available at https://doi.org/10.1542/peds.2021-054271 and will be published in the November issue of Pediatrics.
Adverse events, precautions
Due to its vasoconstrictive properties, oxymetazoline can have serious adverse cardiovascular effects in children when systemically absorbed. These can occur not only with excessive dosing, but also when the product is used following label instructions.
Problems can include hypertension related to the medication’s action on the α2-adrenergic receptors of the smooth muscle of the vasculature. When used in larger doses in young children, oxymetazoline can activate central adrenergic receptors and lead to effects including cardiovascular instability, respiratory depression and sedation, which may be life-threatening.
The medication is intended for short-term use (less than five days) because it may cause rebound nasal congestion. Long-term use can lead to rhinitis medicamentosa. Systemic side effects and end-organ injury are unknown with long-term use.
Correct use of bottle
The amount of product delivered can vary depending on the bottle’s position and how it is squeezed. One case cited a 75-fold increase in medication volume administered when the bottle was inverted.
“People just really need to be careful that when you turn that bottle upside down, it no longer delivers the volume you think you’re supposed to get,” said Joseph D. Tobias, M.D., a report co-author and former chair of the Section on Anesthesiology and Pain Medicine Executive Committee.
Dr. Tobias became interested in the problem in the operating room, as Afrin is used to induce vasoconstriction of the nose when an endotracheal tube is being inserted through the nose and into the trachea.
“There were a smattering of case reports, and we had a couple of events here, where fortunately the kids recovered but had some significant hypertension. In one of them, the hypertension was so bad, (the patient) had left ventricular failure/pulmonary edema — so significant complications,” said Dr. Tobias, who heads the anesthesiology department at Nationwide Children’s Hospital in Columbus, Ohio.
He also knows of a case where a patient died in the operating room.
“The problems we’ve seen have been with large doses, and … I believe this may be a very unique, idiosyncratic reaction,” Dr. Tobias said, adding that some ENT surgeons around the country have never observed the problem.
Still, he urges other health care professionals, especially young anesthesiologists as well as physicians in intensive care units, to consider the precautions recommended.
Need for guidelines
The clinical report calls for dosing guidelines, especially in infants and children. However, pediatric pharmacokinetic data on which to base guidelines are limited.
While the package insert and other sources outline the potential for hypertension and cardiac effects, the clinical report says not enough emphasis has been placed on this in the medical literature.
The following are among AAP recommendations for short-term use of pediatric topical nasal oxymetazoline:
- Clinicians should know the potential adverse cardiovascular effects of unmonitored volume of administration, especially in infants or young children and those with comorbid cardiac conditions.
- Use the spray bottle in an upright position with the child upright, when possible. Use of the medication in the supine position with the bottle inverted can produce a significantly higher dose (about 1 ± 0.5 mL per spray) compared with in the upright position (03 mL per spray).
- Implement a reliable process to track the total volume of medication administered.
- Ensure effective communication between the surgeon and anesthesiologist with intraoperative use of the medications, along with routine monitoring of heart rate, blood pressure and respiration.
- Remove excess medication from the pharynx.
- Encourage pharmacokinetic trials of topical nasal oxymetazoline in the pediatric population for surgical and nonsurgical use. In young children, consider evaluation of the hemostatic efficacy of a half-strength concentration of the agent.