From the Guidelines
Tramadol is not recommended for children under 12 years of age due to safety concerns, and its use in adolescents 12-17 years old should be approached with caution, considering the potential risks of respiratory depression, seizures, and dependence, as highlighted by the FDA guidelines 1.
Key Considerations
- The FDA guidelines restrict the use of tramadol in children younger than 12 years and advise against its use in adolescents aged between 12 and 18 years who are obese or have conditions that increase the risk of serious breathing problems 1.
- Tramadol is not typically dosed by weight (per kilogram) in clinical practice, but rather by a fixed dose, usually starting at 50-100 mg every 4-6 hours as needed for pain, not exceeding 400 mg per day for adults.
- For adolescents 12-17 years old, the recommended starting dose is typically 50-100 mg every 4-6 hours as needed for pain, not exceeding 400 mg per day.
- Caution should be exercised when administering tramadol due to its potential for respiratory depression, seizures, and dependence, and dosage adjustments are necessary for patients with renal or hepatic impairment, and for elderly patients.
Important Safety Information
- Tramadol should be used at the lowest effective dose for the shortest duration possible to minimize risks.
- It's essential to note that tramadol is an opioid medication that works by binding to mu-opioid receptors and inhibiting the reuptake of serotonin and norepinephrine, providing pain relief through multiple mechanisms.
- Always start with lower doses and titrate based on pain control and side effects, as recommended by the guidelines for opioid prescribing in children and adolescents after surgery 1.
From the Research
Tramadol Safety and Dosage in Children
- The safety and efficacy of tramadol in children is a complex issue due to age-related differences in drug responses and limited therapeutic choices 2.
- According to the World Health Organization, weak opioids such as tramadol may be used for moderate nociceptive pain in children, but with caution 2.
- The US Food and Drug Administration has released a boxed warning regarding the use of tramadol in children due to the risk of fatal overdoses linked to variable CYP2D6 activity 2, 3.
- Tramadol is contraindicated in patients under the age of 12 years, as stated by the U.S. Food and Drug Administration in 2017 3.
Recommended Dosage
- A study published in 2022 found that a dose of 1 mg/kg of tramadol was used in children aged 3-16 years, with a novel chewable tablet formulation showing favorable acceptability and reliable relative bioavailability 4.
- Another study published in 2015 found that the weight-normalized oral clearance of tramadol was higher in children and adolescents compared to adults, suggesting that lower doses may be necessary in younger patients 5.
- However, there is no clear consensus on the recommended dosage of tramadol per kilogram in children, and more research is needed to determine the optimal dosing regimen.
Age-Related Considerations
- Tramadol is approved for use in children over 1-3 years of age in some European countries, but with caution due to the risk of poisoning and variability in pharmacokinetic properties 6.
- Children under the age of 12 years are at higher risk of fatal overdoses due to variable CYP2D6 activity, and tramadol is contraindicated in this age group 3.
- A personalized approach to tramadol prescription in children, with dose adaptation according to CYP2D6 activity, may be the safest method 2.