Is diclofenac (Nonsteroidal Anti-Inflammatory Drug (NSAID)) safe for use in a 13-year-old pediatric patient?

Can Diclofenac Be Used in a 13-Year-Old?

Diclofenac can be used in a 13-year-old, though it is not FDA-approved for pediatric use and should be prescribed with caution based on clinical judgment and specific indications. 1

FDA Approval Status and Clinical Reality

• The FDA label explicitly states: "Safety and effectiveness in pediatric patients have not been established." 1
• Despite lack of formal FDA approval, diclofenac is commonly used off-label in pediatric practice, with 86% of pediatric anesthesiologists reporting its use in infants and children 2
• The drug is licensed in some countries for children over 1 year of age for specific conditions like juvenile rheumatoid arthritis 2

When Diclofenac May Be Considered

For pain management:

• Diclofenac is effective for perioperative acute pain in children, significantly reducing the need for rescue analgesia (NNT 3.6) compared to placebo 3
• It provides an opioid-sparing effect when used alone or as adjunct to regional anesthesia 4
• A pharmacokinetic study in adolescents 12-17 years demonstrated favorable safety and tolerability with 50 mg oral doses 5

For inflammatory conditions:

• Although diclofenac can be considered for juvenile idiopathic arthritis at physician discretion 6, naproxen is the preferred NSAID due to its established efficacy and safety profile in children 6, 7

Dosing Considerations for a 13-Year-Old

• Based on pharmacokinetic meta-analysis, recommended doses for children 1-12 years are: 0.3 mg/kg IV, 0.5 mg/kg rectal, or 1 mg/kg oral 8
• For adolescents ≥12 years with migraine, 50 mg oral doses have been studied with acceptable safety 5
• The most commonly used dose in clinical practice is 1 mg/kg every 8 hours 2

Critical Safety Warnings

Cardiovascular risks:

• NSAIDs including diclofenac carry increased risk of serious cardiovascular thrombotic events, MI, and stroke, which can be fatal 1
• This risk may begin as early as the first weeks of treatment 1

Gastrointestinal risks:

• Can cause serious GI adverse events including bleeding, ulceration, and perforation at any time, with or without warning 1
• Only 1 in 5 patients who develop serious upper GI events have warning symptoms 1

Hepatotoxicity:

• Meaningful liver enzyme elevations (>3x ULN) occurred in approximately 2-4% of patients in clinical trials 1

Renal considerations:

• Diclofenac is substantially excreted by the kidney; elderly patients and those with impaired renal function are at greater risk 1

Practical Clinical Approach

Before prescribing:

• Obtain thorough history including cardiovascular risk factors, GI bleeding history, renal function, and hepatic function 1
• Measure baseline blood pressure, serum creatinine (on two separate occasions), liver enzymes, and CBC 6

Monitoring during use:

• Use the lowest effective dose for the shortest duration possible 1
• Monitor for signs of GI bleeding, cardiovascular events, and hepatotoxicity 1
• Avoid concurrent use with other NSAIDs 1

Contraindications:

• Post-CABG surgery 1
• Active GI bleeding or peptic ulcer disease 1
• Severe renal impairment 1
• Known hypersensitivity to diclofenac 1

Alternative Considerations

For most pediatric pain and inflammatory conditions, consider naproxen as first-line NSAID instead of diclofenac 6, 7, as it has:

• Better-established safety profile in children 6
• FDA/EMA approval for pediatric use 6
• Evidence-supported efficacy in juvenile arthritis 7

For simple analgesia, ibuprofen or acetaminophen may be more appropriate first-line options 4, given their broader pediatric approval and safety data.

Bottom Line

While diclofenac can be used in a 13-year-old based on clinical experience and research evidence showing efficacy and acceptable safety 3, 5, it remains an off-label use 1. Serious adverse reactions occur in fewer than 0.24% of children treated for acute pain 3, but the types of reactions mirror those in adults 3. Given the availability of better-studied alternatives like naproxen for chronic conditions 6, 7 and ibuprofen for acute pain 4, diclofenac should be reserved for situations where other NSAIDs are contraindicated, ineffective, or unavailable.