SPRIX in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures

PHASE3CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

June 30, 2015

Study Completion Date

July 31, 2015

Conditions
Pain
Interventions
DRUG

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."

Trial Locations (4)

Unknown

"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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Egalet Ltd

INDUSTRY