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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Pain, Analgesia, Patient-Controlled, Pain, Postoperative

Intervention / Treatment
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* Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem
* Drug: IV Morphine Patient-Controlled Analgesia (IV PCA)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IONSYS<br>IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem | Drug: IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem<br>* 40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day<br>|
| Active Comparator: Patient-Controlled Analgesia<br>IV Morphine Patient-Controlled Analgesia (IV PCA) | Drug: IV Morphine Patient-Controlled Analgesia (IV PCA)<br>* 20mg/2hr (240 mg during 24 hours)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Patient-controlled analgesia, Postoperative pain, Transdermal fentanyl, Surgical pain, Opioid analgesics