Tramadol Dosing in Pediatric Population
Tramadol is not FDA-approved for use in pediatric patients under 16 years of age and is generally not recommended for this population due to safety concerns.
Safety Concerns and FDA Status
- The FDA states that "the safety and efficacy of tramadol hydrochloride in patients under 16 years of age have not been established. The use of tramadol hydrochloride in the pediatric population is not recommended" 1
- Tramadol has a boxed warning regarding its use in children due to the variable activity of cytochrome P450 (CYP) 2D6 which affects its metabolism and safety profile 2
- Like codeine, tramadol's efficacy and safety are largely influenced by CYP2D6 activity, which can vary significantly among children 2
Limited Pediatric Dosing Information
Despite the FDA recommendation against use in children, some clinical guidelines provide dosing information for specific circumstances:
- For postoperative pain management in children, a dose of 1 to 1.5 mg/kg every 4 to 6 hours has been recommended 3
- For breakthrough pain in pediatric wards, the same dosing of 1 to 1.5 mg/kg every 4 to 6 hours has been suggested 3
- Pharmacokinetic studies have shown that children and adolescents have lower area under the curve (AUC) values compared to adults when given similar doses, suggesting potentially different dosing requirements 4
Special Considerations
- Children with lower body weight (<50 kg) have been shown to have even lower drug exposure (AUC) compared to heavier children and adolescents 4
- The weight-normalized oral clearance of tramadol is higher in children and adolescents compared to adults, which may affect dosing requirements 4
- For acute inpatient nociceptive pain management, if tramadol is used, it should be prescribed at the minimal effective dose, in an age-appropriate dosage form, and with clear instructions to parents 2
Alternative Recommendations
- For moderate to severe nociceptive pain conditions in children, morphine is generally preferred over tramadol 2
- If tramadol must be used for chronic or recurrent pain in children, a personalized approach with dose adaptation according to CYP2D6 activity would be the safest method 2
Monitoring and Precautions
- Common adverse effects of tramadol include dizziness, nausea, sedation, dry mouth, and sweating 5
- Tramadol should not be administered to patients receiving monoamine oxidase inhibitors, and administration with tricyclic antidepressant drugs should also be avoided due to risk of serotonin syndrome 5
- Respiratory depression has been observed in some patients, though it appears less common than with other opioids 6