Nasal fentanyl reduces severe pain.

TORONTO -- An investigational nasal spray holds promise as an effective, noninvasive analgesia for children with painful orthopedic injuries, according to a study presented at the annual meeting of the Pediatric Academic Societies.

Intranasal fentanyl relieved moderate to severe orthopedic trauma pain in children in a prospective convenience sample of 81 patients aged 3-18 years.

The finding is noteworthy, as pediatric patients with fractures often don't receive pain medication in the emergency department because of their nothing-by-mouth status and the invasive nature of IV placement, lead investigator Dr. Mary Saunders said.

Fentanyl is approved for intravenous use in the pediatric population, and its transmucosal absorption has been studied in oral mucosa. But it is yet to be approved for use in nasal mucosa, Dr. Saunders said in an interview.

A new mucosal atomization device (made by Wolfe Tory Medical Inc.) allows for dosing by weight, minimizes ingestion and aspiration, and provides uniform delivery, said Dr. Saunders, who disclosed no relevant conflicts of interest. The cost is about $2.45 per dose.

Dr. Saunders and her colleagues in the division of pediatric emergency medicine at the University of Utah, Salt Lake City, recorded pain scores and vital signs at baseline and at 10, 20, and 30 minutes in 81 patients after administration of intranasal fentanyl 2 mcg/kg. The average dose was 1.9 mcg/kg.

At admission, the median pain score was 5 of 6 faces on the Wong-Baker FACES Pain Rating Scale among 53 patients, aged 3-8 years; and 69.2 mm on a 100-mm Visual Analog Scale (VAS) among 28 patients, aged 9-18 years. The average age of the patients was 8 years, and 61% were male.

Fracture types included forearm (47%, of which 68% required reduction), supracondylar (21%), clavicle (9%), tibia/fibula (6%), and other (17%). Patients with multiple trauma, and hemodynamic instability were excluded from the study.

Median pain scores in the Wong-Baker group decreased significantly at 10 minutes (3 faces), 20 minutes (2 faces), and 30 minutes (2 faces).

Significant decreases were also observed in the VAS group at 10 minutes (49 mm), 20 minutes (45 ram), and 30 minutes (45 mm). In all, 60 of the 81 patients (74%) had a significant decrease in their pain score.

Of the 21 patients reporting inadequate pain relief, 10 were in the Wong-Baker group and 11 in the VAS group.

Mean satisfaction scores, based on surveys completed after the 30-minute pain assessment and using a 100-mm VAS, were 74 mm for parents, 79 mm for providers, and 62 mm for patients.

Four parents and six patients said they would not use the drug again, said Dr. Saunders, now at the Medical College of Wisconsin, Milwaukee.

No patient was redosed with intranasal fentanyl, although rescue medication was given to 8 of 21 patients who reported in significant pain relief at the 20-minute pain assessment.

No patient reported burning or a noxious odor with fentanyl administration. No patient had an adverse event.

When asked by an audience member if intranasal fentanyl aided IV placement for those children who required a reduction, Dr. Saunders said that some patients were so miserable they didn't care about the IV, whereas others used their injured arms to push away the nursing staff.

BY PATRICE WENDLING

Chicago Bureau