NCT02102516

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

A Single Arm, Open Label Study of the Safety, Efficacy, and Pharmacokinetics of SPRIX (Intranasal Ketorolac Tromethamine) in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Egalet Ltd · Industry
• Sex: All
• Age: 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.

Detailed description

Evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.

Conditions

• Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-06-01
• Completion: 2015-07-01
• First posted: 2014-04-03
• Last updated: 2017-03-17

Locations

4 sites across 1 country: Poland