Can diclofenac (Nonsteroidal Anti-Inflammatory Drug (NSAID)) be given to adolescents?

Can Diclofenac Be Given to Adolescents?

Yes, diclofenac can be given to adolescents aged 12-17 years, though it is not FDA or EMA approved for pediatric use and should be used at the discretion of the treating physician based on clinical experience. 1

Regulatory Status and Clinical Use

• Diclofenac lacks formal FDA or EMA approval for pediatric populations, distinguishing it from other NSAIDs like ibuprofen and naproxen that have established pediatric indications 1
• Despite the absence of regulatory approval, the Pan-American League of Associations for Rheumatology (PANLAR) acknowledges that diclofenac can be considered for adolescents when prescribed by experienced clinicians 1
• Naproxen is the preferred first-line NSAID for adolescents with conditions like polyarticular juvenile idiopathic arthritis due to its proven efficacy and safety profile in pediatric populations 1

Evidence for Efficacy and Safety

Pharmacokinetic Profile in Adolescents

• A Phase 4 study in adolescents aged 12-17 years demonstrated that diclofenac potassium oral solution (50 mg dose) is rapidly absorbed with a median time to maximum concentration of 15 minutes 2
• The pharmacokinetic profile showed a mean peak plasma concentration of 1412 ng/mL and a half-life of approximately 67 minutes, indicating rapid onset and clearance 2
• Over a 3-month safety period, participants took the drug an average of 10 times with favorable tolerability—no deaths or discontinuations due to adverse events occurred 2

Clinical Efficacy Data

• Diclofenac has demonstrated effectiveness as an analgesic for perioperative acute pain in children, significantly reducing the need for rescue analgesia compared to placebo (NNT 3.6) 3
• When compared to non-NSAID analgesics, diclofenac recipients experienced less nausea and vomiting (NNT 7.7) 3
• The drug shows comparable efficacy to established NSAIDs in adults, with fast onset and long duration of analgesic action 4

Safety Considerations

• Serious adverse reactions with diclofenac occur in fewer than 0.24% of children treated for acute pain, with reaction types similar to those seen in adults 3
• The most common adverse events in adolescents (12-17 years) were arthralgia and motion sickness, each occurring in 8% of participants 2
• There is no evidence of increased perioperative bleeding requiring surgical intervention when diclofenac is used in the perioperative period 3
• Gastrointestinal adverse effects are possible, as with all NSAIDs, though serious ulceration is rare 4

Clinical Decision-Making Algorithm

When considering diclofenac for adolescents:

1. First-line approach: Use FDA/EMA-approved NSAIDs (ibuprofen, naproxen) as initial therapy 1

2. Consider diclofenac when:

   • Approved NSAIDs are contraindicated, unavailable, or ineffective 1
   • Rapid onset of action is clinically important (e.g., acute migraine, severe pain) 2
   • The prescriber has clinical experience with diclofenac in this age group 1

3. Dosing considerations:

   • For adolescents 12-17 years: 50 mg dose has been studied with favorable safety 2
   • Limit to no more than 2 doses daily and not more than 3 days per week for migraine 2
   • Higher loading/maintenance doses may be needed in children compared to adults due to increased clearance 5

4. Monitoring requirements:

   • Assess for gastrointestinal symptoms 4
   • Monitor for bleeding complications if used perioperatively 3
   • Evaluate efficacy within 48-72 hours and adjust treatment if inadequate response 6

Important Caveats

• Asthmatic children require particular caution, as more research on safety in this population is needed 3
• The lack of regulatory approval means prescribers assume greater responsibility for informed consent and monitoring 1
• For conditions like juvenile idiopathic arthritis, naproxen remains the evidence-based first choice unless specific contraindications exist 1
• Diclofenac should not delay initiation of disease-modifying therapy when indicated for inflammatory conditions 1