An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients
Primary Purpose
Pain, Postoperative, Pediatrics
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
fentanyl iontophoretic transdermal system (40mcg) No placebo
fentanyl iontophoretic transdermal system (40mcg)
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring IONSYS™, Pain, Postoperative, Analgesia, Patient-Controlled, Opioids, Pediatrics
Eligibility Criteria
Inclusion Criteria:
- The patients must: weigh >= 40 kg
- be scheduled for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery
- Be expected by the investigator's staff to require injected opioid analgesia for at least 24 hours after surgery
- Be judged by the investigator's staff to be capable of understanding and cooperating with the requirements of the study.
Exclusion Criteria:
- Patients who have undergone any surgery on the airway, head or neck
- Patients who are expected to require intensive care
- Patients who require airway(breathing) support after their surgery
- Patients who received intra-operative (during surgery) and/or post-operative (after surgery) administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil or alfentanil
- Patients with active generalized skin disorders or active local skin disease that precludes the application of fentanyl iontophoretic transdermal system(40 mcg).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
001
Arm Description
Outcomes
Primary Outcome Measures
Any adverse events will be recorded. Oxygen saturation will be monitored continuously. Vital signs (BP, HR, RR, T), oxygen saturation, and concomitant medications will be recorded at Hours 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and every 4 hours thereafter.
Secondary Outcome Measures
Patient Global Assessment, Investigator Global Assessment and Parent Assessment of Patient Use will be completed every 24 hours. Serum fentanyl concentration will be collected at Hours 3, 6,12, and 24.
Full Information
NCT ID
NCT00666393
First Posted
April 22, 2008
Last Updated
February 28, 2014
Sponsor
Alza Corporation, DE, USA
1. Study Identification
Unique Protocol Identification Number
NCT00666393
Brief Title
An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients
Official Title
An Open-Label Evaluation of Safety of the IONSYS System [Fentanyl Iontophoretic Transdermal System (40ug) for Management of Acute Post-Operative Pain in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Program Cancelled.
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alza Corporation, DE, USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients.
Detailed Description
This will be a multicenter, open-label study in which hospitalized pediatric post-operative patients will receive the fentanyl HCl 40 mcg system for up to 3 consecutive days. After their surgery, patients will be brought to the recovery room for initial observation following general or regional anesthesia for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery. Post surgery procedures will be preformed and when analgesia is required, the patient will be titrated to analgesic comfort (a pain score < 4 on a scale 0-10) for at least 30 minutes with an intravenous opioid as clinically appropriate. After a patient has been comfortable (pain intensity of < 4 on 0 -10 color visual analog scale ) for > 30 minutes and has been monitored during recovery and is awake, able to answer questions and follow commands he/she will be assessed for pain intensity, vital signs, and oxygen saturation (amount of oxygen in the blood). If the patient meets study entry criteria, baseline assessments (pain intensity, vital signs, and oxygen saturation) will be completed and the fentanyl HCl 40 mcg system will be applied. During the first 3-hours of the treatment, if a patient successfully completed an on-demand dose and pain relief was still inadequate, the patient could deliver another dose of fentanyl, or be re-titrated to comfort with single or multiple intravenous doses of supplemental opioid medication (IV fentanyl or IV morphine) per study physician's clinical discretion. Supplemental IV doses of opioid medications can be administered in the first 3-hours of system application, but are prohibited after Hour 3. If pain control is judged inadequate with the combined use of fentanyl HCl 40 mcg system and the use of supplemental analgesia, the patient may be withdrawn from the study. Patients will receive fentanyl HCl 40 mcg system. Fentanyl will be delivered upon patient activation over 10 minutes for a maximum of 6 doses/hour for up to 24 hrs or 80 total doses whichever occurs first for up to three consecutive days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pediatrics
Keywords
IONSYS™, Pain, Postoperative, Analgesia, Patient-Controlled, Opioids, Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fentanyl iontophoretic transdermal system (40mcg) No placebo
Intervention Description
40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
Intervention Type
Drug
Intervention Name(s)
fentanyl iontophoretic transdermal system (40mcg)
Intervention Description
40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
Primary Outcome Measure Information:
Title
Any adverse events will be recorded. Oxygen saturation will be monitored continuously. Vital signs (BP, HR, RR, T), oxygen saturation, and concomitant medications will be recorded at Hours 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and every 4 hours thereafter.
Time Frame
Safety outcomes will be collected at intervals throughout the drug system application for a maximum of 72 hours.
Secondary Outcome Measure Information:
Title
Patient Global Assessment, Investigator Global Assessment and Parent Assessment of Patient Use will be completed every 24 hours. Serum fentanyl concentration will be collected at Hours 3, 6,12, and 24.
Time Frame
Patient, Investigator and Parent Assessments of the treatment will be completed every 24 hours for a maximum of 72 hours. Pharmacokinetic measurements will be completed 4 times during every 24 hours of treatment for a maximum of 12 times over 72 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients must: weigh >= 40 kg
be scheduled for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery
Be expected by the investigator's staff to require injected opioid analgesia for at least 24 hours after surgery
Be judged by the investigator's staff to be capable of understanding and cooperating with the requirements of the study.
Exclusion Criteria:
Patients who have undergone any surgery on the airway, head or neck
Patients who are expected to require intensive care
Patients who require airway(breathing) support after their surgery
Patients who received intra-operative (during surgery) and/or post-operative (after surgery) administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil or alfentanil
Patients with active generalized skin disorders or active local skin disease that precludes the application of fentanyl iontophoretic transdermal system(40 mcg).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alza Corporation Clinical Trial
Organizational Affiliation
ALZA
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients
We'll reach out to this number within 24 hrs