This Open-Label Study Will Evaluate in Daily Clinical Practice the Safety and Efficacy of a Fentanyl Iontophoretic Transdermal System (Fentanyl ITS) for Management of Moderate to Severe Acute Pain in Postoperative Patients Who Have Undergone Elective Spine or Orthopaedic Surgery.
Information source: Janssen Cilag N.V./S.A.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Fentanyl Iontophoretic Transdermal System (fentanyl ITS) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Janssen Cilag N.V./S.A. Official(s) and/or principal investigator(s):
Janssen-Cilag N.V./S.A., Belgium Clinical Trial, Study Director, Affiliation: Janssen Cilag N.V./S.A.
Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com
Summary
This open-label study will evaluate in daily clinical practice the safety and efficacy of a
fentanyl Iontophoretic Transdermal System (fentanyl ITS) for management of moderate to severe
acute pain in postoperative patients who have undergone elective spine or orthopaedic
surgery.
Clinical Details
Official title: Clinical Outcome Study in Postoperative Pain Management to Demonstrate the Efficacy and Safety of IONSYS (Fentanyl ITS Iontophoretic Transdermal System) in Daily Clinical Practice and to Assess Its Convenience.
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The use of IV line during treatment with fentanyl ITS will be evaluated. Therefore we will document (24h, 48h, EOT) the amount of patients who have an IV line and compare the actual usage of the IV line with the intended use of the IV line.
Secondary outcome: Patient, physician and nurses' satifaction of treatment
Detailed description:
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy
of a fentanyl Iontophoretic Transdermal System (fentanyl ITS) for management of moderate to
severe acute pain in postoperative patients who have undergone elective spine or orthopaedic
surgery. There will be a focus on the analysis of the use of IV lines and the administration
of intravenous medication for opioid related side effects or for additional analgesia during
the use of fentanyl ITS. Therefore we will document (at each time point) the amount of
patients who have an IV line and compare the actual usage of the IV line with the intended
use of the IV line. The exact moment of first oral intake as well as the exact moment of
discontinuation of the IV line will be recorded, if applicable. Patients are expected to
require parenteral opioids for at least 48 hours postoperatively. This study will also
evaluate patients', nurses' and physicians' assessment of fentanyl ITS under routine
conditions. All adverse events will be documented. The delayed occurrence of application side
reactions after removal of the device will be followed-up. The study treatment phase can last
up to 72 hours.
40 mg fentanyl transdermally per on-demand dose, each delivered over 10 min for a maximum of
6 doses/h (240 mg/h) for 24 h or a maximum of 80 doses (3. 2 mg). Each system will inactivate
at 80 doses or 24 h, whichever occurs first. A new system will be applied every 24 h unless
the patient has used 80 doses in less than 24 h. In this case a new system can be applied
earlier. This system will be changed again at the 24 h time point. A maximum treatment
duration of 72 h is allowed.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult, aged 18 or older, male or female
- Patients who will undergo elective spine or orthopaedic surgery
- Patients who are expected to have moderate or severe pain requiring parenteral opioids
for at least 48 hours after surgery
- Patients who have been admitted to the PACU after general anaesthesia, spinal
anaesthetic of < 4 hours duration of action or epidural anaesthesia. Patients who are
alert and breathing spontaneously for at least 30 minutes in the PACU
- Respiratory rate 10 to 24 breaths per minute
- Patients with a pain score less than or equal to 4 out of 10 on a Numerical Rating
Scale (NRS) at movement of the operated limb or body region, after titration to
comfort according to current postoperative procedures
- Patients who are expected to remain hospitalised for at least 48 hours
postoperatively
Exclusion Criteria:
- Patients with chronic pain disorder (DSM-IV 307. 80/89 - ICD 10: F45. 4)
- Patients with active systemic skin disease or active local skin disease that precludes
fentanyl ITS application
- Patients who received regular treatment with transdermal strong opioids within 14 days
prior to surgery
- Patients who have received peri-operative administration of opioids other than
morphine, fentanyl, sufentanil, alfentanil or remifentanil
- Patients who need postoperatively very high doses of opioids for pain control (more
than 40 mg morphine/h equivalent or more than 60 mg pritramid to reach comfort zone
(NRS £ 4)) or when more than 6 hours have elapsed since the patient arrived in the
PACU
- Patients who are being treated in the intensive care unit
- Patients who will probably require additional surgical procedures within 72 hours
- Patients who are intubated or have a laryngeal mask airway (LMA) at the time of final
screening assessments (T0)
Locations and Contacts
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com
Edegem 2650, Belgium; Recruiting
Brussel 1090, Belgium; Recruiting
Additional Information
To learn how to participate in this trial please click here.
Starting date: July 2008
Last updated: October 31, 2008
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