Clinical trial NCT00996177: A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously
Official title: Comparison of Transdermal Fentanyl PCA and IV Morphine PCA in the Management of Postoperative Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Analgesia, Patient-Controlled
Pain, Postoperative
Keywords: Pain
Patient-controlled analgesia
Postoperative pain
Transdermal fentanyl
Surgical pain
Opioid analgesics
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
Collaborators: name: Alza Corporation, DE, USA
First posted: 2009-10-16
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient's global assessment of pain control (poor, fair, good, excellent) 24 hours after start of study treatment
timeFrame: 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 outcomes:
measure: Assessment of pain control by patient and doctor
timeFrame: At 24, 48, and 72 hours after randomization
measure: Pain Intensity, vital signs, and oxygen level in the blood
timeFrame: Hourly through 8 hours and then every 4 hours after randomization
measure: Incidence of adverse events
timeFrame: Throughout study
Other outcomes:
Locations:
city: Wien
country: Austria
city: Brussel
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Aalborg
country: Denmark
city: Kÿbenhavn Nv N/A
country: Denmark
city: Kÿbenhavn Ÿ
country: Denmark
city: Odense C
country: Denmark
city: Ÿrhus C
country: Denmark
city: Boulogne Billancourt Cedex
country: France
city: Le Kremlin Bicetre
country: France
city: Lille Cedex
country: France
city: Montpellier Cedex 5
country: France
city: Nice
country: France
city: Paris
country: France
city: Rennes Cedex 2
country: France
city: Suresnes
country: France
city: Aachen
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Frankfurt / Main
country: Germany
city: Halle
country: Germany
city: Hamburg N/A
country: Germany
city: Jena
country: Germany
city: Kiel
country: Germany
city: Kÿln
country: Germany
city: Mainz
country: Germany
city: Marburg
country: Germany
city: Ulm
country: Germany
city: Cork
country: Ireland
city: Madrid
country: Spain
city: Göteborg
country: Sweden
city: Huddinge N/A
country: Sweden
city: Linköpng N/A
country: Sweden
city: Stockholm
country: Sweden
city: Örebro
country: Sweden
city: Genève
country: Switzerland
city: Luzern
country: Switzerland
city: St Gallen
country: Switzerland
city: Zuerich
country: Switzerland
city: Zurich
country: Switzerland
city: Edinburgh
country: United Kingdom
city: London
country: United Kingdom
city: N/a N/a
country: United Kingdom
city: Salford
country: United Kingdom
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Grond S, Hall J, Spacek A, Hoppenbrouwers M, Richarz U, Bonnet F. Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007 Jun;98(6):806-15. doi: 10.1093/bja/aem102.