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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02395653
Recruitment Status : Completed
First Posted : March 23, 2015
Results First Posted : September 18, 2017
Last Update Posted : October 26, 2017
Incline Therapeutics, Inc.
Information provided by (Responsible Party):
The Medicines Company

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: fentanyl Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 29, 2015
Actual Primary Completion Date : September 12, 2016
Actual Study Completion Date : September 12, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SSEC Fentanyl
SSEC fentanyl iontophoretic transdermal system, 40 mcg fentanyl per activation.
Drug: fentanyl
An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.
Other Name: IONSYS

Primary Outcome Measures :
  1. Assessment Of Participant's Ability To Use The SSEC [ Time Frame: Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration) ]
    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.

  2. Assessment Of Adherence Of The SSEC System To Skin [ Time Frame: Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours) ]
    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.

Secondary Outcome Measures :
  1. Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal [ Time Frame: Baseline, 1 hour and 24 hours after SSEC removal. ]
    Skin irritation at the SSEC application site was to be assessed immediately prior to placement of the study system and at 1 and 24 hours after removal of each study system. The application site was to be scored using the following scale: 0=No evidence of irritation; 1=Minimal erythema, barely perceptible; 2=Definite erythema, readily visible, minimal edema, or minimal papular response; 3=Erythema and papules; 4=Definite edema; 5=Erythema, edema, and papules; 6=Vesicular eruption; 7=Strong reaction spreading beyond the application site.

  2. Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD) [ Time Frame: From the time of application of the first system through 7 days following end of study drug administration. ]
    Respiratory function and occurrence of CRRD was defined as simultaneous occurrence of bradypnoea (respiratory rate <10 breaths per minute for participants 9-15 years of age and sustained for 1 minute, or <8 breaths per minute for participants 16-17 years of age), with excessive sedation (that is, the participant is not easily aroused).

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395653

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United States, California
Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
United States, Florida
University of Miami/Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
United States, Maryland
Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center
Baltimore, Maryland, United States, 21287
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
The Medicines Company
Incline Therapeutics, Inc.
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Principal Investigator: Elliot J Krane, MD Stanford Children's Health

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Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT02395653    
Other Study ID Numbers: PD2013-002
2014-002405-37 ( EudraCT Number )
First Posted: March 23, 2015    Key Record Dates
Results First Posted: September 18, 2017
Last Update Posted: October 26, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Medicines Company:
Pain Management
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General