A study of the safety and usefulness of fentanyl 40 mcg in the management of pain for up to 72 hours following surgery in patients aged 12 to less than 18 years.

Phase 1

• Conditions: Postoperative pain in pediatric inpatients; MedDRA version: 19.0Level: LLTClassification code 10036286Term: Post-operative painSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-002405-37-Outside-EU/EEA
• Lead Sponsor: Incline Therapeutics Inc, a wholly owned subsidiary of The Medicines Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-11
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients whose parent(s) or guardian(s) have/has signed and dated an informed consent form for the patient to participate in the study, or patients who have provided written assent to participate in the study.
2. Male or female inpatients, age 12 to < 18 years of age inclusive on the day of surgery
3. Patients capable of understanding and cooperating with the requirements of the study, including being able to report their pain intensity using the 11-point NRS and operate the SSEC.
4. American Society of Anesthesiologists (ASA) physical status I, II or III.
5. Body weight of at least 40.0 kg.
6. Postoperative patients who have undergone general or regional anaesthesia for abdominal, pelvic/genitourinary, orthopaedic, or thoracic surgery.
7. Postoperative patients who have been observed during recovery and are expected to remain hospitalized and have pain requiring parenteral opioids (i.e., IV PCA) for the next 24 hours or longer.
8. Patients who are awake and breathing spontaneously with a respiratory rate of 14 to 18 breaths per minute, SpO2 =93% (with or without supplemental oxygen), and able to answer questions and follow commands.
9. Patients 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Patients who have undergone any surgery on the airway, head, or neck.
2. Patients 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 patient-controlled epidural analgesia.
3. Patients with a history of allergy or hypersensitivity to fentanyl, skin adhesives, and/or cetylpyridinium chloride.
4. Patients who are expected to require intensive care or will likely require additional surgical procedures within 36 hours.
5. Patients 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 mg/kg IV is permitted during recovery for shivering.
6. Patients who require airway support (nasal or oropharyngeal airway intubation, or laryngeal mask airway [LMA]) at the time of final baseline assessments (i.e., at the time of IONSYS application [Hour 0]).
7. Patients 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.
8. Patients with active generalized skin disorders or active local skin disease that precludes SSEC application to the chest or upper arm.
9. Patients 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.
10. Positive pregnancy test for any female.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and clinical utility of the active, separated system with enhanced controller (SSEC) fentanyl 40 mcg for the management of acute, postoperative pain in pediatric patients, 12 to less than 18 years of age.;Secondary Objective: Not applicable;Primary end point(s): Safety Endpoints:<br>• Changes in vital signs from baseline, including clinically relevant respiratory depression<br>• Changes in skin irritation assessments from baseline<br>• Incidence of adverse events (AEs) and serious adverse events (SAEs)<br>;Timepoint(s) of evaluation of this end point: 10 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Clinical Utility Endpoints :<br>• Evaluation of the patient's ability to use SSEC<br>• Assessment of adherence of the SSEC system<br><br>Pharmacokinetic Endpoint:<br>• Serum fentanyl concentration at each time point will be assessed<br><br>Other Endpoints:<br>• Pain intensity scores<br>• Pain intensity ratings<br>• Patient, parent/guardian, and investigator global assessments<br>• Opioid rescue medication<br>;Timepoint(s) of evaluation of this end point: Timepoints up to 72 hours