NCT01324544

Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain

A Multicenter, Inpatient, Open-label Study to Characterize the Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Aged From Birth to 6 Years of Age (Inclusive) Who Require Opioid Analgesia for Acute Moderate to Severe Pain

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.

Detailed description

A study of the PK, safety, and efficacy of IV buprenorphine in acute moderate to severe pain in male and female pediatric patients aged from birth to 6 years, inclusive, requiring continuous opioid analgesic treatment for at least 24 hours and up to 72 hours.

Conditions

• Other Acute Postoperative Pain
• Prolonged Endotracheal Intubation

Interventions

Type	Name	Description
DRUG	Buprenorphine IV	Buprenorphine IV administered via patient-controlled analgesia (PCA) pump for at least 24 hours and up to 72 hours.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2011-03-29
• Last updated: 2016-02-04