A Study to Evaluate the Safety and Tolerability of Fentanyl Iontophoretic Transdermal System (Fentanyl-ITS) in the Management of Post-Surgery Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Fentanyl-ITS
Intervention description: Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) will release fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment will be 72 hours.
Intervention MeSH terms: Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 174.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative Pain; Fentanyl Hydrochloride; IONSYS

Summary:

      The purpose of this study is to evaluate the safety and tolerability of the fentanyl
      iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice
      for management of acute (a quick and severe form of illness in its early stage) moderate to
      severe post-operative pain (pain after surgery) including the comprehensibility and
      usefulness of the accompanying information material.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with American Society of Anesthesiology (specialty concerned with the
             study of anesthetics [drug that is used to produce loss of pain sensation] and
             anesthesia [loss of sensation or feeling]) pre-operative physical status 1, 2 or 3

          -  Participants who are expected to remain hospitalized for at least 24 hours
             post-operatively (after the surgery)

          -  Participants, after an elective major surgical procedure (surgery which could be
             postponed or not done at all without danger to the participant), who are expected to
             have moderate or severe pain requiring parenteral (administration by injection)
             opioids (morphine like medications) for at least 24 hours after surgery

          -  Participants who are capable of understanding and cooperating with the requirements of
             the study and operating a transdermal (through the skin) Patients-Controlled Analgesia
             (PCA; methods of pain relief that may be used with or in place of analgesics [drug
             used to control pain])

          -  Participants with a pain score less than or equal to 4 (moderate pain) out of 10 on a
             Numerical Rating Scale (NRS), whereas 0 corresponds to no pain and 10 to the strongest
             imaginable pain at movement of the operated limb or body region, after titration (slow
             increase in drug dosage, guided by participant's responses) to comfort according to
             current postoperative procedures

        Exclusion Criteria:

          -  Participants allergic or hypersensitive (very sensitive) to fentanyl or
             cetylpyridinium chloride or to skin adhesives

          -  Participants who are known or suspected to be strong opioid dependent, or who have a
             very high a need for strong opioids before entering the study

          -  Participants with a history of psychological opioid dependence before the start of the
             study

          -  Participants who are known or suspected to have abused any drug substance or alcohol
             in the opinion of the investigator

          -  Women who are pregnant, breast feeding, or planning to breast feed within 24 hrs of
             the last dose of study drug.