From the Research
The recommended dose of diclofenac for pediatric patients is 1 mg/kg for oral administration, as it yields a similar area under the diclofenac concentration-time curve to 50 mg in adults, according to the most recent and highest quality study available 1.
Diclofenac Dosing Considerations
When considering the use of diclofenac in pediatric patients, it is essential to take into account the age, weight, and formulation of the medication.
- For children aged 1 year and older, the typical oral dose is 1 mg/kg, with a maximum daily dose that should be determined based on the child's weight and the specific condition being treated.
- Diclofenac should be used at the lowest effective dose for the shortest duration possible to minimize side effects, which can include gastrointestinal, renal, and cardiovascular issues.
- The medication works by inhibiting cyclooxygenase enzymes, reducing prostaglandin production, and thereby decreasing inflammation and pain.
Administration and Monitoring
- Diclofenac should be administered with food to reduce stomach irritation.
- Children should be monitored for signs of adverse reactions, and the medication should be adjusted or discontinued if necessary.
- Alternative pain management options should be considered for children under 1 year of age, as diclofenac is not FDA-approved for this age group.
Evidence-Based Recommendations
The recommendation for a 1 mg/kg oral dose of diclofenac is based on a pharmacokinetic meta-analysis that aimed to define the pharmacokinetics of intravenous, oral, and rectal diclofenac in children and to recommend a dose that would yield an equivalent area under the diclofenac concentration-time curve to a 50-mg dispersible tablet in adults 1.
- This study used data from 111 children aged 1-14 years and found that a single dose of 1 mg/kg for oral diclofenac in children aged 1-12 years is recommended.
- More recent studies, such as the 2023 Cochrane review, have highlighted the uncertainty surrounding the benefits and harms of diclofenac for acute postoperative pain in children, but the 2011 study by 1 remains the highest quality evidence for dosing recommendations.