TABLE 3.
Recommended Pediatric Studies for Different Analgesic Classes
| Drug Class | Recommended Studies: Acute Use (<1 wk) | Recommended Studies: Subacute Use (1–3 wk) | Recommended Studies: Chronic Use (≥1 mo) |
|---|---|---|---|
| Acetaminophen | Efficacy (extrapolation to age 2 y; special emphasis on <3 mo of age) PK (all ages) Dose response (all ages) Safety (hepatic toxicity) | PK (all ages) Dose response (all ages) Safety (hepatic toxicity) | Rarely indicated for chronic pain in pediatrics Not recommended for chronic headache in pediatrics |
| Antiinflammatory Agents: Nonsteroidal antiinflammatory drugs Coxibs | Efficacy (extrapolation to age 2 y; special emphasis on <3 mo of age) PK (all ages) Dose response (all ages) Safety (gastric, renal toxicity) | Efficacy (extrapolation to age 2 y) PK (ages ≥2) Dose response Safety (gastric, renal toxicity) | Efficacy for selected antiinflammatory indications, age >2 y PK (ages ≥2) Dose response Safety (gastric, renal, hepatic toxicity) |
| μ Receptor Opioids | Efficacy (extrapolation to age 2 y) PK (all ages) Dose response (all ages) Safety (CNS toxicity, respiratory sensitivity) | Efficacy (extrapolation to age 2 y) PK (all ages) Dose response (all ages) Safety (CNS toxicity, immune response, withdrawal) | Small, heterogeneous populations for study; consider small-sample designs Safety (CNS toxicity, immune response, withdrawal) |
| Mixed Receptor Opioids | Efficacy (all ages) PK (all ages) Dose response Safety (CNS toxicity, respiratory sensitivity) | Efficacy (all ages) PK (all ages) Dose response (all ages) Safety (CNS toxicity, immune response, withdrawal) | Small, heterogeneous populations for study; consider small-sample designs Safety (CNS toxicity, immune response, withdrawal) |
| Local anesthetics | PK (all ages) Dose response (all ages) Safety (surrogate measures of CNS toxicity, cardiotoxicity) Postoperative infusion studies over 2–4 d | Rarely indicated for use beyond 1 wk | Rarely indicated for use beyond 1 wk |
| Antiepileptic drugs | Not applicable (used predominantly for chronic pain rather than acute pain) | Not applicable (used predominantly for chronic pain rather than acute or subacute pain) | Efficacy: Migraine prophylaxis and functional abdominal disorders in adolescents Consider small-sample designs for neuropathic pain and fibromyalgia PK Dose response Safety (CNS, psychiatric toxicity) |
| Antidepressants | Not applicable (used predominantly for chronic pain rather than acute pain) | Not applicable (used predominantly for chronic pain rather than acute or subacute pain) | Efficacy: Migraine prophylaxis and functional abdominal disorders in adolescents Consider small-sample designs for neuropathic pain and fibromyalgia PK Dose response Safety (CNS, psychiatric toxicity) |
CNS, central nervous system.