Clinical trial NCT02395653: Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
Official title: An Open Label Evaluation of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Pediatric
Postoperative
Pain Management
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
Collaborators: name: Incline Therapeutics, Inc.
First posted: 2015-03-23
Enrollment: 71
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: An open label evaluation of the safety and clinical utility of the active, SSEC fentanyl 40 mcg for the management of acute postoperative pain in pediatric participants 12 to less than 18 years of age.

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

Primary outcomes:
measure: Assessment Of Participant's Ability To Use The SSEC
timeFrame: Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)
measure: Assessment Of Adherence Of The SSEC System To Skin
timeFrame: Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)
Secondary outcomes:
measure: Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal
timeFrame: Baseline, 1 hour and 24 hours after SSEC removal.
measure: Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)
timeFrame: From the time of application of the first system through 7 days following end of study drug administration.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Packard Children's Hospital at Stanford
state: California
city: Miami
country: United States
facility: University of Miami/Jackson Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center
state: Maryland
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Stanford Children's Health
name: Elliot J Krane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chelly JE, Grass J, Houseman TW, Minkowitz H, Pue A. The safety and efficacy of a fentanyl patient-controlled transdermal system for acute postoperative analgesia: a multicenter, placebo-controlled trial. Anesth Analg. 2004 Feb;98(2):427-433. doi: 10.1213/01.ANE.0000093314.13848.7E.
citation: Grond S, Hall J, Spacek A, Hoppenbrouwers M, Richarz U, Bonnet F. Iontophoretic transdermal system using fentanyl compared with patient-controlled intravenous analgesia using morphine for postoperative pain management. Br J Anaesth. 2007 Jun;98(6):806-15. doi: 10.1093/bja/aem102.
citation: Hartrick CT, Bourne MH, Gargiulo K, Damaraju CV, Vallow S, Hewitt DJ. Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: a comparative study with morphine intravenous patient-controlled analgesia. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):546-54. doi: 10.1016/j.rapm.2006.08.011.
citation: Minkowitz HS, Rathmell JP, Vallow S, Gargiulo K, Damaraju CV, Hewitt DJ. Efficacy and safety of the fentanyl iontophoretic transdermal system (ITS) and intravenous patient-controlled analgesia (IV PCA) with morphine for pain management following abdominal or pelvic surgery. Pain Med. 2007 Nov-Dec;8(8):657-68. doi: 10.1111/j.1526-4637.2006.00257.x.
citation: Minkowitz HS, Yarmush J, Donnell MT, Tonner PH, Damaraju CV, Skowronski RJ. Safety and tolerability of fentanyl iontophoretic transdermal system: findings from a pooled data analysis of four clinical trials. J Opioid Manag. 2010 May-Jun;6(3):203-10. doi: 10.5055/jom.2010.0018.
citation: Viscusi ER, Reynolds L, Chung F, Atkinson LE, Khanna S. Patient-controlled transdermal fentanyl hydrochloride vs intravenous morphine pump for postoperative pain: a randomized controlled trial. JAMA. 2004 Mar 17;291(11):1333-41. doi: 10.1001/jama.291.11.1333.
citation: Viscusi ER, Reynolds L, Tait S, Melson T, Atkinson LE. An iontophoretic fentanyl patient-activated analgesic delivery system for postoperative pain: a double-blind, placebo-controlled trial. Anesth Analg. 2006 Jan;102(1):188-94. doi: 10.1213/01.ane.0000183649.58483.77.
citation: Viscusi ER, Siccardi M, Damaraju CV, Hewitt DJ, Kershaw P. The safety and efficacy of fentanyl iontophoretic transdermal system compared with morphine intravenous patient-controlled analgesia for postoperative pain management: an analysis of pooled data from three randomized, active-controlled clinical studies. Anesth Analg. 2007 Nov;105(5):1428-36, table of contents. doi: 10.1213/01.ane.0000281913.28623.fd.