What is the minimum age for diclofenac use in children, and what are the recommended pediatric dosing and contraindications?

Minimum Age for Diclofenac Use in Children

Diclofenac is not FDA or EMA approved for pediatric use at any age, but clinical experience supports its use in children ≥1 year old when other NSAIDs are contraindicated or unavailable, with naproxen or ibuprofen preferred as first-line alternatives. 1

Regulatory Status and Clinical Practice

• Diclofenac lacks regulatory approval for pediatric use in most jurisdictions, though it is licensed in some countries for children >1 year of age specifically for juvenile rheumatoid arthritis 2
• The Pan-American League of Associations for Rheumatology (PANLAR) acknowledges that while diclofenac lacks formal pediatric approval, clinical experience supports its use when other NSAIDs are contraindicated or unavailable 1
• Use of diclofenac in children should be at the discretion of the treating physician based on clinical experience and individual patient circumstances 1

Preferred First-Line NSAIDs in Children

• Naproxen is the preferred NSAID for children with polyarticular juvenile idiopathic arthritis due to its evidence-supported efficacy and safety profile 1
• Ibuprofen is widely used and well-studied in children >6 months of age, though it is generally not recommended for infants under 6 months 1
• If naproxen or ibuprofen are contraindicated or unavailable, alternative NSAIDs with FDA or EMA approval for pediatric use include: indomethacin, meloxicam, tolmetin, etodolac, ketorolac, oxaprozin, and celecoxib 1

Evidence-Based Dosing When Diclofenac Is Used

Perioperative Pain (Ages 1-12 Years)

• Intravenous: 0.3 mg/kg as a single dose 3
• Rectal suppository: 0.5 mg/kg as a single dose 3
• Oral: 1 mg/kg as a single dose 3
• These doses yield an area under the curve (AUC) equivalent to 50 mg in adults and are based on pharmacokinetic meta-analysis 3

Common Clinical Practice Patterns

• The most commonly used dose in clinical practice is 1 mg/kg every 8 hours, with oral (81%) and rectal (80%) routes being most frequent 2
• Diclofenac is used by 78% of pediatric anesthesiologists intraoperatively and is part of the analgesic regimen for adenotonsillectomies in 57% of cases 2

Safety Profile in Children

• Serious adverse reactions occur in fewer than 0.24% of children treated with diclofenac for acute pain 4
• The types of serious adverse reactions are similar to those reported in adults, but these events are rare 4
• There is no increased risk of perioperative bleeding requiring surgical intervention when diclofenac is used in the perioperative period, with the possible exception of tonsillectomy where controversy exists 4, 5
• Compared with other non-NSAIDs, patients receiving diclofenac experience less nausea or vomiting (relative risk 0.6; number needed to treat 7.7) 4

Topical Formulation for Minor Injuries (Ages 6-16 Years)

• The FLECTOR (diclofenac epolamine) topical system has been studied in children aged 6-16 years for minor soft tissue injuries 6
• Applied twice daily, it provides safe and effective pain relief with minimal systemic NSAID exposure and low potential for local or systemic adverse events 6
• Maximum tolerability score was 1 (faint redness), with only 8.7% of patients experiencing possibly treatment-related adverse events (none serious) 6

Critical Caveats

• Pharmacokinetic and pharmacodynamic data are lacking in infants <1 year of age, making dosing recommendations in this population unreliable 2, 5
• More research is needed on optimum dosing and safety in asthmatic children before routine use can be recommended 4
• Children have increased volume of distribution and clearance compared with adults, which may necessitate higher loading or maintenance doses 5
• Always consider approved alternatives first (naproxen, ibuprofen) before resorting to off-label diclofenac use 1