What decongestant can be safely used in a 14‑month‑old infant weighing approximately 10–12 kg?

No Decongestant Should Be Used in a 14-Month-Old Child

Over-the-counter decongestants—both oral and topical—should be avoided entirely in children under 6 years of age due to documented fatalities, lack of proven efficacy, and serious safety concerns including neurological toxicity and cardiovascular complications. 1, 2

Why Decongestants Are Contraindicated at This Age

Documented Mortality and Serious Adverse Events

• Between 1969 and 2006, there were 54 documented decongestant-related fatalities in children under 6 years, with 43 of these deaths occurring in infants below 1 year of age. 2
• Four fatalities were specifically associated with phenylephrine in children under 6 years. 2
• Use in infants and young children has been directly associated with agitated psychosis, ataxia, hallucinations, and death—even at recommended doses. 1, 2

Narrow Therapeutic Window

• Topical vasoconstrictors should be used with extreme care below age 1 year because of the narrow margin between therapeutic and toxic dose, which significantly increases the risk for cardiovascular and CNS side effects. 1
• At 14 months, your patient remains in this high-risk category where the margin of safety is unacceptably narrow. 1

Lack of Proven Efficacy

• The efficacy of cold and cough medications for symptomatic treatment of upper respiratory tract infections has not been established for children younger than 6 years. 1
• Oral phenylephrine is extensively metabolized in the gut and its efficacy as an oral decongestant has not been well established. 1, 2

Official Regulatory Position

• The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended that OTC medications used to treat cough and cold no longer be used for children below 6 years of age. 2, 3
• The American Academy of Allergy, Asthma, and Immunology explicitly states that the use of these OTC drugs generally should be avoided in all children below 6 years of age due to potential toxicity. 1, 2

Safe and Effective Alternatives for Nasal Congestion

First-Line Treatment: Saline Irrigation

• Saline nasal irrigation is the recommended primary treatment for nasal congestion in infants, as it helps remove debris from the nasal cavity and temporarily reduces tissue edema to promote drainage. 3
• Saline irrigation has demonstrated greater improvement in nasal airflow, quality of life, and total symptom scores compared to placebo in pediatric patients. 3

Supportive Non-Pharmacologic Measures

• Gentle nasal suctioning with a bulb syringe or nasal aspirator to clear secretions and improve breathing is a recommended first-line option. 2, 3
• Maintain adequate hydration through continued breastfeeding or formula feeding to help thin secretions. 2
• Use a supported sitting position during feeding and rest to help expand lungs and improve respiratory symptoms. 2

When to Seek Further Medical Evaluation

Red Flags Requiring Immediate Assessment

• Oxygen saturation <92% or cyanosis. 3
• Respiratory rate >70 breaths/min (in infants <1 year). 3
• Difficulty breathing, grunting, or intermittent apnea. 3
• Not feeding or signs of dehydration. 3

Indications for Follow-Up

• If nasal congestion persists beyond 10 days without improvement, or is accompanied by fever ≥39°C (102.2°F) for at least 3 days, or worsens after initial improvement, medical evaluation should be sought to rule out bacterial sinusitis. 3

Critical Clinical Pitfall to Avoid

The most common error is using multiple cold/cough products simultaneously or making dosing errors, which were common mechanisms leading to the documented fatalities in this age group. 2 Even if a parent or caregiver insists on medication, the evidence-based recommendation remains clear: no decongestant of any kind should be used in a 14-month-old child. 1, 2, 3