Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: fentanyl
Intervention description: An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric; Postoperative; Pain Management

Summary:

      The objective of this study is to evaluate the safety and clinical utility of the active,
      SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in
      pediatric participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants whose parent(s) or guardian(s) have/has signed and dated an informed
             consent form for the participant to participate in the study, or participants who have
             provided written assent to participate in the study

          -  Male or female inpatients, age 12 to <18 years of age inclusive on the day of surgery

          -  Participants capable of understanding and cooperating with the requirements of the
             study, including being able to report their pain intensity using the 11-point Numeric
             Rating Scale and operate the SSEC

          -  American Society of Anesthesiologists physical status I, II or III

          -  Body weight of at least 40.0 kilogram (kg)

          -  Postoperative participants who have undergone general or regional anesthesia for
             abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery

          -  Postoperative participants who have been observed during recovery and are expected to
             remain hospitalized and have pain requiring parenteral opioids (that is, intravenous
             [IV] patient-controlled anesthesia) for the next 24 hours or longer

          -  Participants who are awake and breathing spontaneously with a respiratory rate of 14
             to 18 breaths per minute, peripheral capillary oxygen saturation ≥93% (with or without
             supplemental oxygen), and able to answer questions and follow commands

          -  Participants who have been observed during recovery, who are awake, able to answer
             questions and follow commands, and who have been comfortable for at least 30 minutes,
             with a pain intensity score ≤4 (numeric rating scale 0-10), with or without titration
             to comfort with IV opioids

        Exclusion Criteria:

          -  Participants who have undergone any surgery on the airway, head, or neck

          -  Participants who received an extended-release opioid within 48 hours prior to Hour 0
             or who are expected to have postoperative analgesia supplied by a continuous regional
             technique or participant-controlled epidural analgesia

          -  Participants with a history of allergy or hypersensitivity to fentanyl, skin
             adhesives, and/or cetylpyridinium chloride

          -  Participants who are expected to require intensive care or will likely require
             additional surgical procedures within 36 hours

          -  Participants who received intra-operative and/or postoperative administration of
             opioids other than morphine, hydromorphone, fentanyl, sufentanil, or alfentanil.
             Exception: If there are no medical contraindications, meperidine (pethidine) up to 0.5
             milligram/kg IV is permitted during recovery for shivering

          -  Participants who require airway support (nasal or oropharyngeal airway intubation, or
             laryngeal mask airway at the time of final baseline assessments (that is, at the time
             of IONSYS application [Hour 0])

          -  Participants who are known or suspected to be opioid tolerant, have a history of
             opioid dependence within 3 months before the start of the study, or who are known to
             have used illicit drugs or alcohol within 14 days of the start of the study

          -  Participants with active generalized skin disorders or active local skin disease that
             precludes SSEC application to the chest or upper arm

          -  Participants with any coexisting major medical conditions that are likely to interfere
             with study procedures including, but not limited to, psychiatric conditions, chronic
             depression, suicidal ideation, autism

          -  Positive pregnancy test for any female