NCT00666393

An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients

An Open-Label Evaluation of Safety of the IONSYS System [Fentanyl Iontophoretic Transdermal System (40ug) for Management of Acute Post-Operative Pain in Pediatric Patients

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alza Corporation, DE, USA · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients.

Detailed description

This will be a multicenter, open-label study in which hospitalized pediatric post-operative patients will receive the fentanyl HCl 40 mcg system for up to 3 consecutive days. After their surgery, patients will be brought to the recovery room for initial observation following general or regional anesthesia for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery. Post surgery procedures will be preformed and when analgesia is required, the patient will be titrated to analgesic comfort (a pain score \< 4 on a scale 0-10) for at least 30 minutes with an intravenous opioid as clinically appropriate. After a patient has been comfortable (pain intensity of \< 4 on 0 -10 color visual analog scale ) for \> 30 minutes and has been monitored during recovery and is awake, able to answer questions and follow commands he/she will be assessed for pain intensity, vital signs, and oxygen saturation (amount of oxygen in the blood). If the patient meets study entry criteria, baseline assessments (pain intensity, vital signs, and oxygen saturation) will be completed and the fentanyl HCl 40 mcg system will be applied. During the first 3-hours of the treatment, if a patient successfully completed an on-demand dose and pain relief was still inadequate, the patient could deliver another dose of fentanyl, or be re-titrated to comfort with single or multiple intravenous doses of supplemental opioid medication (IV fentanyl or IV morphine) per study physician's clinical discretion. Supplemental IV doses of opioid medications can be administered in the first 3-hours of system application, but are prohibited after Hour 3. If pain control is judged inadequate with the combined use of fentanyl HCl 40 mcg system and the use of supplemental analgesia, the patient may be withdrawn from the study. Patients will receive fentanyl HCl 40 mcg system. Fentanyl will be delivered upon patient activation over 10 minutes for a maximum of 6 doses/hour for up to 24 hrs or 80 total doses whichever occurs first for up to three consecutive days.

Conditions

• Pain, Postoperative
• Pediatrics

Interventions

Type	Name	Description
DRUG	fentanyl iontophoretic transdermal system (40mcg) No placebo	40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
DRUG	fentanyl iontophoretic transdermal system (40mcg)	40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-04-24
• Last updated: 2014-03-03