What are the guidelines for using diclofenac (nonsteroidal anti-inflammatory drug (NSAID)) gel in children?

Diclofenac Gel Use in Children

Diclofenac gel is not FDA or EMA approved for pediatric use and lacks supporting evidence in children, though it may be considered at the treating physician's discretion based on clinical experience for specific conditions like juvenile idiopathic arthritis. 1

Regulatory Status and Evidence Base

• Diclofenac 3% gel in 2.5% hyaluronic acid is licensed specifically for adult patients with actinic keratosis, not for pediatric populations. 2
• No pediatric studies exist for topical diclofenac gel, making its use in children off-label and unsupported by evidence. 2
• The gel formulation was studied exclusively in adults for dermatologic conditions (actinic keratosis), not for musculoskeletal pain or other pediatric indications. 2

Clinical Context: Systemic Diclofenac in Children

While topical gel lacks pediatric data, systemic diclofenac (oral/rectal/IV) has been studied in children:

• Diclofenac is an effective analgesic for perioperative acute pain in children aged ≥1 year, with serious adverse reactions occurring in fewer than 0.24% of treated children. 3
• The American College of Rheumatology lists diclofenac among NSAIDs used at therapeutic dosing in juvenile idiopathic arthritis (JIA), though it is not specifically highlighted as a preferred agent. 1
• The Pan-American League of Associations for Rheumatology (PANLAR) 2025 guidelines state that although diclofenac is not FDA or EMA approved for pediatric use, it can be considered at the discretion of the treating physician based on clinical experience in children with polyarticular JIA. 1

Preferred Alternatives in Pediatric Practice

For children requiring NSAID therapy, naproxen is the preferred first-choice NSAID due to its evidence-supported efficacy and safety profile in pediatric populations. 1

• If naproxen is contraindicated or unavailable, alternative NSAIDs with FDA/EMA approval for pediatric use include: ibuprofen, indomethacin, meloxicam, tolmetin, etodolac, ketorolac, oxaprozin, and celecoxib. 1
• Naproxen can be dosed at 5-7.5 mg/kg every 12 hours in adolescents, calculated based on body weight. 2
• Ibuprofen is licensed for use in children weighing over 7 kg and is commonly used postoperatively. 4

Systemic Diclofenac Dosing (When Used Off-Label)

For systemic formulations in children aged 1-12 years (based on pharmacokinetic meta-analysis):

• Intravenous: 0.3 mg/kg single dose 5
• Rectal suppository: 0.5 mg/kg single dose 5
• Oral: 1 mg/kg single dose 5
• Most commonly used dose in clinical practice: 1 mg/kg every 8 hours (rectal route 80% of cases, oral 81%). 4

Critical Safety Considerations

• Diclofenac causes similar types of serious adverse reactions in children as in adults, but these are rare (fewer than 0.24%). 3
• Compared with other non-NSAIDs, diclofenac reduces nausea/vomiting (NNT 7.7). 3
• No increase in bleeding requiring surgical intervention has been observed in perioperative settings, except for ongoing controversy regarding ketorolac use in tonsillectomy. 3, 6
• More research on optimum dosing and safety in asthmatic children is required. 3

Common Pitfalls to Avoid

• Do not assume topical diclofenac gel has the same evidence base as systemic formulations—the gel is studied only in adults for dermatologic conditions. 2
• Do not use diclofenac gel as first-line therapy in children when evidence-based alternatives like naproxen or ibuprofen are available. 1
• Injectable diclofenac (75 mg IM/IV) has no established pediatric dosing for adolescents. 2
• Acetylsalicylic acid (aspirin) should not be used in children with JIA despite FDA/EMA approval due to controversial efficacy, safety concerns, and toxicity risks. 1

Breastfeeding Context

• Diclofenac is considered safe to use during breastfeeding, as small amounts are detected in breast milk and it has been used extensively during lactation. 1