45
Participants
Start Date
March 31, 2014
Primary Completion Date
June 30, 2015
Study Completion Date
July 31, 2015
SPRIX(intranasal ketorolac tromethamine)
"Dose: Subjects weighing 3.0 kg received 3.15 mg (1 spray/1 nostril), subjects weighing 5.1 - 10.0 kg received 5.25 mg (1 spray/1 nostril), subjects weighing 10.1 - 15.4 kg received 10.5 mg (1 spray/1 nostril), subjects weighing 15.5 - 31.7 kg received 15.75 mg (1 spray/1 nostril), and subjects weighing \>=31.8 kg received 31.5 mg (1 spray/2 nostrils).~Duration of Treatment: Subjects received a dose of SPRIX every 6 hours from the day of surgery until the morning of post-operative Day 2. Dosing may have resumed after final PK assessment of the morning of post-operative Day 3 until post-operative Day 4. A follow-up phone interview took place 14 days after the final dose of study drug."
"Instytut Centrum Zdrowia Matki Polki (Institute Mother's Memorial Hospital)", Lodz
Klinika Chirurgii i Traumatologii Dzieciecej - Dzieciecy Szpital Kliniczny im. prof. Antoniego Gebali, Lublin
Regional Hospital of Ludwika Rydygiera in Torun, Torun
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu - Independent Public Clinical Hospital No. 1 in Wroclaw, Wroclaw
Lead Sponsor
Egalet Ltd
INDUSTRY