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

Phase 4

Completed

• Conditions: Pain; Analgesia, Patient-Controlled; Pain, Postoperative
• Interventions: Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem; Drug: IV Morphine Patient-Controlled Analgesia (IV PCA)

• Registration Number: NCT00996177
• Lead Sponsor: Janssen-Cilag International NV

Brief 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).

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2009-09-28
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 657

Inclusion Criteria

• Patients who meet the criteria of American Society of Anesthesiology (ASA) pre-operative physical status I, II, or III
• Patients expected to have moderate or severe pain after a major abdominal or orthopedic procedure
• Patients expected to remain hospitalized for at least 24 hours postoperatively

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Exclusion Criteria

• Known allergy or hypersensitivity to fentanyl, morphine, or to skin adhesives
• Known or suspected to be dependent on strong opioids or to have abused any drug substance or alcohol
• Severe respiratory symptoms
• Chronic pain disorder
• Pregnant or nursing women, or those lacking adequate contraception

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IONSYS	IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem	IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
Patient-Controlled Analgesia	IV Morphine Patient-Controlled Analgesia (IV PCA)	IV Morphine Patient-Controlled Analgesia (IV PCA)

Primary Outcome Measures

Name	Time	Method
Patient's global assessment of pain control (poor, fair, good, excellent) 24 hours after start of study treatment	24 hours after randomization (24 hours after either the first transdermal iontorphoretic system was applied or 24 hours after the intravenous access for the morphine solution was applied).

Secondary Outcome Measures

Name	Time	Method
Assessment of pain control by patient and doctor	At 24, 48, and 72 hours after randomization
Pain Intensity, vital signs, and oxygen level in the blood	Hourly through 8 hours and then every 4 hours after randomization
Incidence of adverse events	Throughout study