Is tramadol (tramadol hydrochloride) safe for a 19 kg child?

Tramadol Use in a 19 kg Child

Tramadol is not recommended for use in a 19 kg child as it is contraindicated in children under 12 years of age due to the risk of respiratory depression and death. 1

Safety Concerns

Tramadol presents significant safety issues in pediatric patients for several reasons:

• FDA Contraindication: The US Food and Drug Administration (FDA) has contraindicated tramadol use in children under 12 years of age due to serious safety concerns 1

• Variable Metabolism: Like codeine, tramadol is metabolized through the CYP2D6 enzyme pathway, which has significant genetic variability 2

  • Ultra-rapid metabolizers may produce excessive amounts of the active metabolite (O-desmethyltramadol)
  • This can lead to opioid toxicity, respiratory depression, and potentially death

• Lack of FDA Approval: According to the FDA drug label, "the safety and efficacy of tramadol hydrochloride in patients under 16 years of age have not been established" 3

Alternative Pain Management Options

For a 19 kg child requiring pain management, consider these safer alternatives:

1. Non-opioid analgesics:

   • Acetaminophen (paracetamol): 15 mg/kg every 4-6 hours
   • Ibuprofen: 10 mg/kg every 6-8 hours (if not contraindicated)

2. For moderate to severe pain requiring opioids:

   • Morphine: This is the preferred agent for moderate to severe pain in children when an opioid is necessary 4
   • Starting dose: 0.1 mg/kg IV/IM every 3-4 hours as needed 5
   • Monitor closely for respiratory depression, sedation, and other adverse effects

Special Considerations

If tramadol were to be used (which is NOT recommended):

• The National Comprehensive Cancer Network suggests a pediatric dose of 1-1.5 mg/kg every 4-6 hours with a maximum of 8 mg/kg/day not exceeding 400 mg per day 6
• However, this conflicts with the FDA contraindication and should not be followed for children under 12 years

Monitoring and Precautions

When using any opioid in children:

• Monitor respiratory status continuously
• Assess sedation level regularly
• Have naloxone readily available for reversal of respiratory depression
• Dosing: 0.1 mg/kg IV/IM (0.1 mg/kg for children <5 years or <20 kg; 2 mg for children ≥5 years or ≥20 kg) 5

Conclusion

Given the significant risks and FDA contraindication, tramadol should not be administered to a 19 kg child. Safer alternatives exist for pain management in this population, with morphine being the preferred opioid when necessary for moderate to severe pain.