1.2. Pediatrics

Fentanyl citrate transmucosal lozenges are FDA-approved for use in adolescents 16 years and older. Fentanyl transdermal patch is FDA-approved for use to manage chronic severe pain in opioid-tolerant pediatric patients 2 years of age and older requiring around-the-clock opiate therapy. Fentanyl nasal spray as well as oral fentanyl buccal tablet, sublingual spray, and sublingual tablet safety and efficacy have not been established in patients below 18 years of age. Pediatric fentanyl maximum dosage recommendations are summarized in Table 7^1-11.

Although not FDA-approved, oral fentanyl citrate has been studied in non-opioid tolerant patients as young as 2 years of age for various indications including surgical procedure pain, wound dressing changes in burn patients, and sedation in single doses ranging from 10-20 mcg/kg given prior to procedures with mixed efficacy rates. Similarly, intranasal fentanyl has been effectively utilized in pediatric patients as young as 6 months of age for non-FDA approved uses (e.g., analgesia, burns, postoperatively) at doses of 1-2 mcg/kg with success^20-29.