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

Pain Clinical Trial

— EuroTrans  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996177
• Other study ID #: CR003943
• Secondary ID: FEN-PPA-4012004-
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2009
• Last updated: January 28, 2014
• Start date: June 2004
• Est. completion date: April 2005

Study information

• Verified date: January 2014
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Janssen-Cilag International NV	Alza Corporation, DE, USA

Countries where clinical trial is conducted

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

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	Assessment of pain control by patient and doctor		At 24, 48, and 72 hours after randomization	No
Secondary	Pain Intensity, vital signs, and oxygen level in the blood		Hourly through 8 hours and then every 4 hours after randomization	No
Secondary	Incidence of adverse events		Throughout study	No