Journal of Pediatric Health Care
Volume 21, Issue 4 , Pages 272-275, July 2007

Use of Over-the-Counter Cough and Cold Medications in Children Younger Than 2 Years

  • Kerri A. Irwin, RN, MSN

      Affiliations

    • Corresponding Author InformationCorrespondence: Kerri A. Irwin, RN, MSN; 2291 Zollinger Road, Upper Arlington, OH 43221

Article Outline

 

Section Editor

 

Mary Margaret Gottesman, PhD, RN, CPNP

Ohio State University College of Nursing

Columbus, Ohio

The common cold or upper respiratory infection (URI) is a self-limiting viral illness that affects people of all ages, especially children. The common cold brings with it many undesirable symptoms such as cough, nasal congestion, rhinorrhea, and sleep loss, which lead tired and frustrated parents to seek treatment. Pediatric health care professionals often recommend over-the-counter (OTC) cough and cold medications as first-line therapy. In these cases, parents need to weigh knowledgeably the risks and benefits before administering these medications to their children.

The average child in the United States will experience 6-8 URIs per year, with day care attendance significantly increasing this number to 10 or more (Heikkinen & Jarvinen, 2003). The occurrence of URIs shows clear seasonality, with an incidence surge in the autumn that remains high through the winter, followed by an incidence decrease in the spring (Heikkinen & Jarvinen). Studies have shown rhinovirus to be the most common cause of URIs in children, with more than 20% of 6-month-old infants and 79% of all 2-year-olds in the United States having had a laboratory confirmed case of rhinovirus (Heikkinen & Jarvinen).

Along with rhinovirus, many other viruses cause URIs in children, all of which spread by each of the following mechanisms: (1) hand contact with secretions containing the virus; (2) inhalation of small-particle, virus-contaminated aerosols in the air; or (3) direct hit from the infected person by large-particle aerosols containing the virus. Rhinovirus infection begins once the virus adheres to the anterior nasal mucosa. From the anterior nasal mucosa, the viruses migrate to the posterior nasopharynx, where they gain entrance to the epithelial cells and begin replication. The shedding of rhinovirus peaks on the second day following nasal inoculation and then rapidly decreases (Heikkinen & Jarvinen, 2003).

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Commonly Used OTC Preparations 

Once infected with a virus, vasodilation and increased vascular permeability occur in the nasal mucosa, causing nasal obstruction and rhinorrhea. These symptoms last an average of 7-10 days, often accompanied by sneezing, cough, headache, and fever. These symptoms frequently cause a decrease in nighttime sleep, which triggers parents to call their primary care professional for advice. Primary care professionals and phone triage personnel often recommend that parents try one or more of the following OTC cold medication classes: decongestants, antitussives, antihistamines, and expectorants.

Decongestants, such as phenylephrine and pseudoephedrine, relieve nasal congestion by constricting the dilated blood vessels in the nasal mucosa following a viral infection. These medications also act peripherally, targeting α and β receptors, potentially causing tachycardia and hypertension. Other common adverse effects in children include irritability, hallucination, and dystonic reactions (Committee on Drugs, 1997).

Cough is a reflex response to mechanical, chemical, or inflammatory irritation of the tracheobronchial tree mediated through neurons in the brain stem or cough center (Committee on Drugs, 1997). Antitussives, such as dextromethorphan, work to decrease cough by directly inhibiting the cough center in the brain and effectively elevating the threshold for coughing. Adverse effects of dextromethorphan in children include behavioral disturbances and respiratory depression (Committee on Drugs, 1997).

Antihistamines such as diphenhydramine work to decrease mucus production and are structurally similar to histamine, thereby preventing its effects at the receptor level. Expectorants such as guaifenesin work to increase bronchial mucus production, thereby making coughs more productive and clearing the airway. Many of these drugs are sold both as single active ingredients and in combination with each other. With more than 100 different formulations available to parents, OTC medication dosing can be confusing for parents, leading to the administration of toxic doses of medications (Carr, 2006).

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Research Findings 

Many studies have examined the use of OTC cough and cold medicines in children. More recently, this topic has resurfaced because of an increase in infant deaths due to OTC cold medicine use (Centers for Disease Control and Prevention [CDC], 2007). Schroeder and Fahey (2004) conducted a search of the Cochrane Central Register of Controlled Trials and found seven trials looking at the use of OTC cough and cold medicines in children. These trials looked at the use of antitussives, mucolytics, antihistamine-decongestant combinations, and other drug combinations. Of these trials, two found limited effectiveness in relieving the target symptoms. The first (Reece, Cherry, Reece, Hatcher, & Diehl, 1966) is out-of-date, and the second (Korppi, Laurikainen, Pietikaenen, & Silvasti, 1991) is foreign.

Yoder, Shaffer, LaTournas, and Paul (2006) and Paul et al. (2004) both conducted studies comparing the effectiveness of dextromethorphan, diphenhydramine, and placebo in treating nocturnal cough in children with URIs. Yoder et al. based the results on the child’s assessment, while Paul et al. based their results on the parent’s assessment of nocturnal cough symptoms. Both studies found there to be no significant difference between the three treatment groups when assessing cough frequency, impact on sleep quality, and cough severity.

Merenstein, Diener-West, Halbower, Krist, and Rubin (2006) conducted a double-blind, randomized, controlled clinical trial looking at the use of diphenhydramine in infants aged 6-15 months. This study found no difference in nighttime sleep between the placebo and treatment group. Conduct of the study was stopped by the Data Safety Monitoring Board.

Not only have OTC cough and cold medicines been found to be no more effective than placebo, but more importantly, they also have been found to be harmful. The CDC (2007) found that approximately 1500 children younger than 2 years were treated in U.S. emergency departments for adverse effects, including overdoses, between 2004 and 2005. The CDC and National Association of Medical Examiners investigated the deaths of infants associated with OTC cough and cold medicines. In 2005, the deaths of three infants younger than 6 months were examined and all were found to have cough and cold medicines as the underlying cause of death. The most prominent drug associated with death was pseudoephedrine (Wingert, Mundy, Collins, & Chmara, 2007). All three of these infants had excessive levels of OTC cough and cold medicines in their bloodstream, ultimately leading to their early deaths.

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Recommendations 

In children younger than 2 years, OTC cough and cold medicines have been shown to be no more effective than placebo in reducing the symptoms of the common cold. Given this lack of data and the known potential toxic adverse effects, the American Academy of Pediatrics issued a policy in 1997 advising pediatric health care professionals to educate parents regarding the lack of antitussive effects, the risk for adverse events, including death, and the potential for overdose in children from these medications (CDC, 2007). In addition, the American College of Chest Physicians released clinical practice guidelines in 2006 advising health care professionals against recommending OTC cough and cold medications because of the associated morbidity and mortality. Instead, they recommended that pediatric health care professionals focus on parental education concerning the expected brief duration of URI symptoms, comfort measures, and the importance of maintaining adequate hydration. Parents should be encouraged to clear nasal congestion with a rubber suction bulb and to use saline solution drops or a cool-mist humidifier to thin mucus secretions. Studies have shown that complementary and alternative therapies such as echinacea, vitamin C, and zinc have no beneficial effect in treating the URI symptoms and therefore are not recommended for use in children (Simasek & Blandino, 2007). Despite education efforts, if parents decide to use OTC cough and cold medications, they should be reminded of the importance of safe storage of OTC cough and cold medicines to prevent unintentional ingestions and proper dosing.

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Conclusion 

The patient education handout in Box 1 offers guidance to parents in the safe care of their young infant with an upper respiratory infection. Sharing evidence-based information with parents helps them to be knowledgeable caregivers for their children and helps prevent needless harm to children.

Box 1.
The common cold in children

WHAT CAUSES A COLD

•Viruses cause the common cold

•Viruses spread from person to person by:
∘Breathing in viruses

∘Touching objects with viruses on them and then touching your eyes, nose or mouth

∘Direct hit, such as when a sick person sneezes or coughs on you


•The average child has 6 to 8 colds per year, mostly between fall and spring

•Day care attendance increases the number of colds per year a child can have, sometimes more than 10 per year

WHAT DOES A COLD LOOK LIKE IN A CHILD?

•Common cold symptoms are fever, cough, congestion, and runny nose

•Nasal mucous often starts out clear and turns yellow, then green; this is normal in a child with a cold (cells fighting the virus cause the color change)

•Colds can last between 3 and 14 days

WHAT TO DO IF MY CHILD HAS A COLD

•Antibiotics only work against bacteria, not the viruses that cause colds

•Research shows that over-the-counter cough and cold medicines do not work in children younger than 2 years and can be dangerous, even causing death

•Use a rubber suction bulb to remove mucous from your child’s nose

•Use a cool-mist humidifier and nasal saline drops to help thin your child’s mucous and make it easier to expel

•Continue to give your child plenty fluids for hydration and thinning mucous

•Give Tylenol or Motrin in the dose closest to your child’s weight if your child has a fever

WHEN TO CALL THE PRIMARY CARE PROVIDER

•If your child has difficulty breathing, such as nasal flaring, retractions (skin tugging in between ribs and above the tummy when the child breaths in), wheezing (high-pitched squeak when breathing out), or grunting (an “UH!” sound when the child breathes out)

•If your child begins to pull or tug on his or her ears, it may be an ear infection

•If your child has a fever for more than 3-5 days and Tylenol or Motrin do not work

•If your child is not having wet diapers at least every 8 hours

HOW TO PREVENT COLDS

•Always wash your hands and your child’s hands before meals and after using the bathroom or using tissues

•Avoid enclosed public play areas where viruses live

•Always cover your mouth when you cough

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References 

  1. Carr BC. Efficacy, abuse, and toxicity of over-the-counter cough and cold medicines in the pediatric population. Current Opinion in Pediatrics. 2006;18:184–188
  2. Centers for Disease Control and Prevention. Infant deaths associated with cough and cold medications—two states, 2005. MMWR. 2007;56:1–4
  3. Committee on Drugs. Use of codeine- and dextromethorphan-containing cough remedies in children. Pediatrics. 1997;99:918–920
  4. Heikkinen T, Jarvinen A. The common cold. The Lancet. 2003;361:51–59
  5. Merenstein D, Diener-West M, Halbower AC, Krist A, Rubin HR. The trial of infant response to diphenhydramine: The TIRED study—A randomized, controlled, patient-oriented trial. Archives of Pediatric and Adolescent Medicine. 2006;160:707–712
  6. Paul IM, Yoder KE, Crowell KR, Shaffer ML, McMillan HS, Carlson LC, et al. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics. 2004;114:85–90
  7. Shroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database of Systematic Review. 2004;4:
  8. Simasek M, Blandino DA. Treatment of the common cold. American Family Physician. 2007;75:515–520522
  9. Wingert WE, Mundy LA, Collins GL, Chmara ES. Possible role of pseudoephedrine and other over-the-counter cold medications in the deaths of very young children. Journal of Forensic Science. 2007;52:487–490
  10. Yoder KE, Shaffer ML, LaTournas SJ, Paul IM. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clinical Pediatrics. 2006;45:633–640

Kerri A. Irwin is Registered Nurse, The Ohio State University College of Nursing, Columbus, Ohio.

PII: S0891-5245(07)00166-6

doi:10.1016/j.pedhc.2007.04.011

Journal of Pediatric Health Care
Volume 21, Issue 4 , Pages 272-275, July 2007

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