Pediatric Tramadol Dosing
For children aged 7-16 years, administer tramadol 1-2 mg/kg orally every 4-6 hours, with a maximum single dose of 100 mg and a maximum daily dose of 8 mg/kg/day not to exceed 400 mg/day. 1, 2
Standard Dosing Protocol
- The recommended dose is 1 to 1.5 mg/kg every 4 to 6 hours for pediatric patients in postoperative settings and for breakthrough pain management 1
- The maximum daily dose must not exceed 8 mg/kg/day or 400 mg/day, whichever is lower 2
- This dosing regimen has been validated in open-label trials of children aged 7-16 years with painful conditions lasting 7-30 days and was found to be safe and effective 2
Age and Weight Considerations
- Tramadol is approved and studied specifically for children 7 years and older 2, 3
- Children with lower body weight (<50 kg) demonstrate lower area under the curve (AUC) values, suggesting faster clearance, but the standard weight-based dosing (1-2 mg/kg) appropriately accounts for this difference 3
- Weight-normalized oral clearance is higher in children (12.66 mL/min/kg) compared to adults (9.06 mL/min/kg), supporting the use of weight-based rather than fixed dosing 3
Critical Safety Warnings
Absolute Contraindications
- Avoid tramadol in pediatric patients taking SSRIs, SNRIs, tricyclic antidepressants, or MAO inhibitors due to serious risk of serotonin syndrome 4, 1
- Do not use with anticonvulsants that lower seizure threshold 4
Common Adverse Effects
- Expect dizziness, nausea, sedation, and vomiting as the most common side effects in pediatric patients 1, 5
- These adverse effects are dose-dependent, so starting at the lower end of the dosing range (1 mg/kg rather than 2 mg/kg) may improve tolerability 6
Clinical Context
- Tramadol is classified as a WHO Step II weak opioid, appropriate for mild to moderate pain 4
- It is approximately 0.1-0.2 times as potent as morphine, making it unsuitable for severe pain where stronger opioids are indicated 4
- The analgesic effect begins within 1 hour and peaks at 2 hours, with duration of approximately 6 hours after oral administration 6, 5
Important Pitfall to Avoid
Do not use adult fixed-dose regimens (50-100 mg every 4-6 hours) in children, as this fails to account for the pharmacokinetic differences in pediatric patients and may result in either underdosing or overdosing depending on the child's weight 3. Always calculate the dose based on the child's weight using the 1-2 mg/kg formula 1, 2.