NCT02395653

Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants

An Open Label Evaluation of the Safety and Clinical Utility of the Active, Separated System With Enhanced Controller (SSEC) Fentanyl 40 mcg for the Management of Acute Postoperative Pain in Pediatric Patients 12 to Less Than 18 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.

Detailed description

An open label evaluation of the safety and clinical utility of the active, SSEC fentanyl 40 mcg for the management of acute postoperative pain in pediatric participants 12 to less than 18 years of age.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	fentanyl	An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.

Timeline

• Start date: 2015-06-29
• Primary completion: 2016-09-12
• Completion: 2016-09-12
• First posted: 2015-03-23
• Last updated: 2017-10-26
• Results posted: 2017-09-18

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study