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

NCT ID: NCT00996177

Last Updated: 2014-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 657 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2005-04-30

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).

Conditions

Pain; Analgesia, Patient-Controlled; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IONSYS

IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem

Group Type: EXPERIMENTAL

IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem

Intervention Type: DRUG

40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day

Patient-Controlled Analgesia

IV Morphine Patient-Controlled Analgesia (IV PCA)

Group Type: ACTIVE_COMPARATOR

IV Morphine Patient-Controlled Analgesia (IV PCA)

Intervention Type: DRUG

20mg/2hr (240 mg during 24 hours)

Interventions

IONSYS (fentanyl HCl) Iontophoretic TransdermalSystem

40 µg fentanyl on-demand (240µg/hr) or a maximum of 80 doses (3.2 mg) per day

Intervention Type: DRUG

IV Morphine Patient-Controlled Analgesia (IV PCA)

20mg/2hr (240 mg during 24 hours)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alza Corporation, DE, USA

INDUSTRY

Sponsor Role: collaborator

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Vienna, , Austria

Brussels, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Aalborg, , Denmark

Kÿbenhavn Nv N/A, , Denmark

Kÿbenhavn Ÿ, , Denmark

Odense C, , Denmark

Ÿrhus C, , Denmark

Boulogne-Billancourt, , France

Le Kremlin-Bicêtre, , France

Lille, , France

Montpellier, , France

Nice, , France

Paris, , France

Rennes, , France

Suresnes, , France

Aachen, , Germany

Bochum, , Germany

Bonn, , Germany

Frankfurt am Main, , Germany

Halle, , Germany

Hamburg, , Germany

Jena, , Germany

Kiel, , Germany

Kÿln, , Germany

Mainz, , Germany

Marburg, , Germany

Ulm, , Germany

Cork, , Ireland

Madrid, , Spain

Gothenburg, , Sweden

Huddinge, , Sweden

Linköpng N/A, , Sweden

Örebro, , Sweden

Stockholm, , Sweden

Geneva, , Switzerland

Lucerne, , Switzerland

Sankt Gallen, , Switzerland

Zurich, , Switzerland

Edinburgh, , United Kingdom

London, , United Kingdom

N/a N/a, , United Kingdom

Salford, , United Kingdom

Countries

Austria; Belgium; Denmark; France; Germany; Ireland; Spain; Sweden; Switzerland; United Kingdom

References

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.

Reference Type: RESULT

PMID: 17519263 (View on PubMed)

Other Identifiers

FEN-PPA-401

Identifier Type: OTHER

Identifier Source: secondary_id

2004-001201-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR003943

Identifier Type: -

Identifier Source: org_study_id