NCT00996177

A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously

Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 657 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative pain.

Detailed description

This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention) study to evaluate the clinical use, safety and ease of care of two patient-controlled analgesia (PCA) systems to deliver pain medication either through the skin or intravenously. The fentanyl hydrochloride PCA system, which delivers the medication through the skin, and morphine intravenous (IV)- PCA, which requires injection into a vein, are used for management of moderate to severe acute pain in postoperative patients who have undergone elective major abdominal or orthopedic surgery. These patients, who are expected to require postoperative pain relief with strong opioids for at least 24 hours, will control the delivery of medication for up to 3 days. Assessment of effectiveness include: patient's global assessment of pain control (poor, fair, good, excellent); Pain Intensity, measured on a visual numerical rating scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain; Ease-of-Care questionnaires including Patient Ease-of-Care questionnaire, Nurse Ease-of-Care questionnaire, and Physical Therapist Ease-of-Care questionnaire; and, total number of doses delivered by patients in the fentanyl transdermal PCA or morphine IV PCA treatment groups. Safety evaluations include vital signs (pulse, blood pressure) and oxygen saturation, respiratory function, and the incidence of adverse events. The study hypothesis is that fentanyl transdermal PCA is not inferior to morphine IV PCA treatment in patient's global assessment of method of pain control during the first 24 hours after surgery. Transdermal PCA: 40 micrograms fentanyl per on-demand dose, each delivered over 10 minutes for a maximum of 6 doses/hr for 24 hours (maximum of 80 doses, 3.2milligrams). Morphine IV PCA: morphine doses with a maximum of 20 milligrams per 2 hours for 24 hours (maximum 12 doses, 240 milligrams).

Conditions

• Pain
• Analgesia, Patient-Controlled
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem	40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day
DRUG	IV Morphine Patient-Controlled Analgesia (IV PCA)	20mg/2hr (240 mg during 24 hours)

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2009-10-16
• Last updated: 2014-01-29

Locations

44 sites across 10 countries: Austria, Belgium, Denmark, France, Germany, Ireland, Spain, Sweden, Switzerland, United Kingdom