At what age can diclofenac (Nonsteroidal Anti-Inflammatory Drug (NSAID)) and aceclofenac (NSAID) be given to pediatric patients (children) for treatment?

Age Guidelines for Diclofenac and Aceclofenac in Children

Diclofenac can be used in children aged 1 year and older, while aceclofenac should not be used in children under 6 years of age.

Diclofenac Age Recommendations

Regulatory Status and Clinical Practice

• Diclofenac is not FDA or EMA approved for pediatric use, but it can be considered at the discretion of the treating physician based on clinical experience 1.
• Despite lack of formal approval, diclofenac is commonly used off-label in children over 1 year of age, particularly for juvenile rheumatoid arthritis 2.
• The Pan-American League of Associations for Rheumatology (PANLAR) 2025 guidelines acknowledge that while diclofenac lacks regulatory approval for pediatric use, clinical experience supports its use when other NSAIDs are contraindicated or unavailable 1.

Evidence-Based Age Cutoffs

• Pharmacokinetic and efficacy data support use in children aged 1-12 years 3.
• A Cochrane systematic review and pharmacokinetic meta-analysis included children aged 1-14 years, establishing safety and efficacy in this age range 4, 3.
• The majority of clinical studies have focused on children ≥1 year of age undergoing minor surgeries 5.

Dosing Considerations by Age

• For children 1-12 years: 1 mg/kg orally, 0.5 mg/kg rectally, or 0.3 mg/kg intravenously are recommended doses based on pharmacokinetic modeling 3.
• Infants under 1 year: Limited pharmacokinetic and pharmacodynamic data exist for this age group, making routine use not recommended 2, 5.

Aceclofenac Age Recommendations

Regulatory Guidance

• Aceclofenac is not established for children under 6 years of age according to FDA labeling 6.
• The dosage and indication have not been established for children less than 6 years old 6.

Clinical Implications

• Children 6 years and older may receive aceclofenac, though specific dosing guidelines should follow manufacturer recommendations 6.
• No high-quality pediatric studies were identified in the evidence base for aceclofenac, making it a less preferred NSAID compared to alternatives with better pediatric data.

Preferred NSAID Alternatives in Children

First-Line Recommendations

• Naproxen is the preferred NSAID for children with polyarticular juvenile idiopathic arthritis due to its evidence-supported efficacy and safety profile 1.
• Ibuprofen is generally not recommended for infants under 6 months but is widely used and well-studied in children over this age 7.
• For infants under 3 months, acetaminophen is the only recommended analgesic 7.

Alternative NSAIDs with Pediatric Approval

• If naproxen is contraindicated or unavailable, alternative NSAIDs with FDA or EMA approval for pediatric use include: ibuprofen, indomethacin, meloxicam, tolmetin, etodolac, ketorolac, oxaprozin, and celecoxib 1.

Important Clinical Caveats

Safety Considerations

• Serious adverse reactions with diclofenac occur in fewer than 0.24% of children treated for acute pain, with similar types of reactions as seen in adults 4.
• No increased risk of perioperative bleeding has been demonstrated with diclofenac use, except for potential controversy with ketorolac in tonsillectomy 5.
• More research is needed on diclofenac safety in asthmatic children 4.

Pharmacokinetic Differences

• Children have increased volume of distribution and clearance compared to adults for most NSAIDs, potentially requiring higher loading or maintenance doses 5.
• The elimination half-life is similar between children and adults 5.