From the Guidelines
Carbamide peroxide is not recommended for ear wax removal in a 12-month-old child. According to the clinical practice guideline update on earwax (cerumen impaction) published in 2017 1, cerumenolytic agents like carbamide peroxide are not recommended for children under 3 years old. This is because their ear canals are small and delicate, and these products haven't been adequately tested for safety in this age group.
Key Considerations
- The American Academy of Otolaryngology-Head and Neck Surgery recommends avoiding cerumenolytic agents in children under 3 years old due to potential risks and lack of safety data 1.
- For infants and young children, it's best to consult a pediatrician if concerned about ear wax, as they can recommend gentle and safe methods for removal if necessary.
- Gentle methods such as using a few drops of warm olive oil or mineral oil to soften the wax, followed by gentle irrigation with warm water using a soft rubber bulb syringe, may be recommended by a doctor.
Important Safety Precautions
- Never insert cotton swabs or any objects into a child's ear canal, as this can push wax deeper or damage the ear canal or eardrum 1.
- Some ear wax is normal and beneficial, helping to protect the ear canal, and most children's ears are self-cleaning.
- Only excessive wax that causes symptoms or interferes with hearing or examination needs removal, and this should be done under medical supervision for children this young.
From the FDA Drug Label
Directions FOR USE IN THE EAR ONLY adults and children over 12 years of age: ... children under 12 years: consult a doctor
The use of carbamide peroxide for ear wax removal in a 12-month-old child is not recommended without consulting a doctor, as the label specifically advises to consult a doctor for children under 12 years 2.
From the Research
Ear Wax Removal in 12-Month-Olds
- The use of carbamide peroxide for ear wax removal in children, including 12-month-olds, has been studied in the context of various ear drop solutions 3.
- Carbamide peroxide is a hydrogen peroxide-urea compound used to soften and remove ear wax, and its effectiveness and safety have been compared to other ear drop solutions, such as oil-based compounds and water-based compounds 3.
- However, the evidence from the study does not specifically address the use of carbamide peroxide in 12-month-old children, as the study focuses on adults and children in general, without providing age-specific data 3.
Safety and Efficacy of Ear Drops
- The study found that active treatment with ear drops, including carbamide peroxide, may result in a higher proportion of ears with complete clearance of ear wax compared to no treatment 3.
- However, there is no evidence to suggest that one type of ear drop is more effective than another, including carbamide peroxide, in terms of complete wax clearance or adverse effects 3.
- The study also notes that the overall risk of bias across the included studies was low or unclear, and the quality of the evidence for each outcome was assessed using GRADE, with most outcomes having low-quality evidence 3.
Adverse Effects
- The study reports that adverse effects, such as discomfort, irritation, or pain, were mild and rare, with no significant differences between the types of ear drops, including carbamide peroxide 3.
- However, the study notes that the available information on adverse effects was limited, and more research is needed to fully understand the safety profile of ear drops, including carbamide peroxide, in children 3.