Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants

NCT02395653 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: PD2013-0022014-002405-37
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 10

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.

Conditions

Pain, Postoperative

Keywords

Pediatric; Postoperative; Pain Management

Outcome Measures

Primary Outcomes (2)

• Assessment Of Participant's Ability To Use The SSEC

  Investigator's assessment of participant's ability to use the SSEC system safely and effectively. The assessment consisted of a 4-level categorical evaluation (poor, fair, good, and excellent). Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.

  Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)

• Assessment Of Adherence Of The SSEC System To Skin

  The adhesion of each SSEC was evaluated immediately prior to removal at each 24-hour time point, or at early withdrawal. Adhesion was recorded using the following classification: System adhered to at least 90% of the application area with no edges unattached; System adhered between 75% and 89%; System was \<75% adhered and not taped; System was secured with tape. The number of SSEC systems for all time points in each category is presented. Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.

  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 (2)

• Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal

  Baseline, 1 hour and 24 hours after SSEC removal.

• Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)

  From the time of application of the first system through 7 days following end of study drug administration.

Study Arms (1)

SSEC Fentanyl

EXPERIMENTAL

SSEC fentanyl iontophoretic transdermal system, 40 mcg fentanyl per activation.

Drug: fentanyl

Interventions

fentanyl DRUG

An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.

Also known as: IONSYS

SSEC Fentanyl

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Medicines Company: lead
• Incline Therapeutics, Inc.: collaborator

Study Sites (10)

Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

University of Miami/Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center

Baltimore, Maryland, 21287, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (8)

• 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.

  PMID: 14742382 BACKGROUND

• 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.

  PMID: 17519263 BACKGROUND

• 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.

  PMID: 17138198 BACKGROUND

• 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.

  PMID: 18028044 BACKGROUND

• 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.

  PMID: 20642249 BACKGROUND

• 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.

  PMID: 15026400 BACKGROUND

• 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.

  PMID: 16368828 BACKGROUND

• 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.

  PMID: 17959978 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Global Health Science Center
• Organization: The Medicines Company

medical.information@themedco.com

1-888-977-6326

Study Officials

• Elliot J Krane, MD

  Stanford Children's Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 23, 2015
• Study Start: June 29, 2015
• Primary Completion: September 12, 2016
• Study Completion: September 12, 2016
• Last Updated: October 26, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-09

Locations

US (10)