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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
71
An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.
Packard Children's Hospital at Stanford
Palo Alto, California, United States
University of Miami/Jackson Memorial Hospital
Miami, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
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.
Time frame: 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.
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)
Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score 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.
Time frame: Baseline, 1 hour and 24 hours after SSEC removal.
Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)
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Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center
Baltimore, Maryland, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Harborview Medical Center
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
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).
Time frame: From the time of application of the first system through 7 days following end of study drug administration.