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. - Full Text View

Sponsored by:	Janssen Cilag N.V./S.A.
Information provided by:	Janssen Cilag N.V./S.A.
ClinicalTrials.gov Identifier:	NCT00779038

Purpose

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.

Condition	Intervention	Phase
Pain, Postoperative	Drug: Ionsys	Phase IV

MedlinePlus related topics: Surgery

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Janssen Cilag N.V./S.A.:

Primary Outcome Measures:

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. [ Time Frame: 24 hours, 48 hours and at end of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient, physician and nurses' satifaction of treatment [ Time Frame: The questionnaires will be completed at the end of the treatment phase. ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	July 2008
Study Completion Date:	September 2008

Arms	Assigned Interventions
001: Experimental	Drug: Ionsys 1 device per 24 hour

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779038

Sponsors and Collaborators

Janssen Cilag N.V./S.A.

Investigators

Study Director:

Janssen-Cilag N.V./S.A., Belgium Clinical Trial

Janssen Cilag N.V./S.A.

More Information

No publications provided

Responsible Party:	Janssen Cilag N.V./S.A. ( Director Medical Affairs )
Study ID Numbers:	CR015121, FENHYDPAI4014, 2008-002074-35
Study First Received:	October 23, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00779038 History of Changes
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Cilag N.V./S.A.:

IONSYS
Fentanyl Iontophoretic Transdermal System
Postoperative pain

Study placed in the following topic categories:

Anesthetics, Intravenous
Fentanyl
Adjuvants, Immunologic
Anesthetics
Central Nervous System Depressants
Pain
Narcotics

Signs and Symptoms
Postoperative Complications
Anesthetics, General
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid
Pain, Postoperative

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pain
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Signs and Symptoms

Pathologic Processes
Postoperative Complications
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid
Pain, Postoperative

ClinicalTrials.gov processed this record on May 07, 2009