From the Research
Diclofenac can be given to pediatric patients aged 6 years and older, with a recommended dose of 0.3 mg/kg for intravenous, 0.5 mg/kg for suppositories, and 1 mg/kg for oral diclofenac, yielding a similar area under the diclofenac concentration-time curve to 50 mg in adults. For pediatric patients aged 6-16 years, diclofenac may be prescribed at appropriate doses, with adjustments based on weight and clinical response, as evidenced by a phase IV non-randomized clinical trial 1. The medication should be used at the lowest effective dose for the shortest duration possible to minimize potential side effects. Diclofenac carries risks of gastrointestinal, cardiovascular, and renal adverse effects, which are of particular concern in pediatric patients. For children younger than 6, alternative NSAIDs such as ibuprofen or naproxen are typically preferred as they have more established safety profiles and dosing guidelines in pediatric populations.
Key Considerations
- The age restriction for diclofenac exists because children have different pharmacokinetics than adults and may be more susceptible to certain adverse effects, particularly those affecting the gastrointestinal tract and kidneys.
- A pharmacokinetic meta-analysis has been undertaken to recommend a dose for children aged 1-12 years, suggesting single doses of 0.3 mg/kg for intravenous, 0.5 mg/kg for suppositories, and 1 mg/kg for oral diclofenac 2.
- The FLECTOR topical system has been shown to safely and effectively provide pain relief for minor soft tissue injuries in the pediatric population, with minimal systemic nonsteroidal anti-inflammatory drug exposure and low potential risk of local or systemic adverse events 1.
- A Cochrane review assessed the efficacy and safety of diclofenac for acute postoperative pain management in children, but the evidence certainty was very low for all outcomes, making it difficult to draw meaningful conclusions 3.
Recommendations
- For pediatric patients aged 6 years and older, diclofenac may be prescribed at appropriate doses, with adjustments based on weight and clinical response.
- The medication should be used at the lowest effective dose for the shortest duration possible to minimize potential side effects.
- Alternative NSAIDs such as ibuprofen or naproxen are typically preferred for children younger than 6, as they have more established safety profiles and dosing guidelines in pediatric populations.