Safety of Naproxen and Domperidone in a 13-Year-Old
Naproxen can be safely used in a 13-year-old, but domperidone should only be used with caution in children over 12 years of age for short-term treatment of nausea and vomiting.
Naproxen Use in 13-Year-Olds
Naproxen is approved for use in pediatric patients over 2 years of age, with established safety and efficacy data for juvenile arthritis 1. The FDA-approved dosing guidelines state:
- For children over 2 years: 2.5-5 mg/kg as a single dose
- Total daily dose should not exceed 15 mg/kg/day
- Naproxen suspension is typically used for precise pediatric dosing
Safety considerations for naproxen in adolescents:
- Well-tolerated in pediatric patients over 2 years of age
- Primarily excreted by the kidney, so renal function should be monitored
- As with all NSAIDs, there are risks of gastrointestinal effects, though these are less common in younger patients compared to elderly patients 1
Domperidone Use in 13-Year-Olds
Domperidone use in pediatric patients requires more caution:
- Current guidelines restrict its use to relief of nausea and vomiting in children older than 12 years for a short period of time 2
- Since the patient is 13 years old, they meet the minimum age requirement, but careful consideration is needed
Safety concerns with domperidone:
- Cardiac safety issues have been identified, including QT prolongation and potential arrhythmias 3
- In 2014, safety warnings were issued in multiple countries regarding cardiac risks in children 4
- Should not be administered to patients with:
- Pre-existing QT prolongation
- Patients receiving CYP3A4 inhibitors
- Electrolyte abnormalities
- Other risk factors for QT prolongation 3
Evidence for Efficacy in Pediatrics
- A 2019 randomized controlled trial found that low-dose domperidone (0.25 mg/kg three times daily) was not significantly better than placebo for treating nausea and vomiting in children with acute gastroenteritis 5
- For gastroesophageal reflux disease (GERD) in children, a Cochrane review found no significant benefit of domperidone 6
Recommendations for Clinical Practice
If considering domperidone for a 13-year-old:
- Use only for short-term treatment of nausea and vomiting (not for GERD or other off-label indications)
- Prescribe the lowest effective dose (0.25 mg/kg three times daily)
- Limit duration to less than 7 days 4
- Screen for cardiac risk factors and drug interactions before prescribing
- Monitor for adverse effects, particularly cardiac symptoms
For naproxen in a 13-year-old:
- Use appropriate weight-based dosing (2.5-5 mg/kg per dose)
- Do not exceed 15 mg/kg/day total daily dose
- Monitor for gastrointestinal symptoms
- Consider using with food to minimize GI effects
Key Cautions
- Domperidone is used off-label in many countries for GERD and gastroparesis, but evidence for efficacy in children is limited 2
- Cardiac safety concerns have led to restricted use of domperidone in pediatric patients
- Naproxen is generally safe in adolescents but should be used at the lowest effective dose for the shortest duration needed
When prescribing these medications for a 13-year-old, the benefits must clearly outweigh the risks, particularly for domperidone given its cardiac safety profile and limited evidence of efficacy in pediatric patients.