An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients
February 28, 2014 updated by: Alza Corporation, DE, USA
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
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.
Study Overview
Status
Withdrawn
Conditions
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with the combined use of fentanyl HCl 40 mcg system and the use of supplemental analgesia, the patient may be withdrawn from the study.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.
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 001
|
40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
Safety outcomes will be collected at intervals throughout the drug system application for a maximum of 72 hours.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Anticipated)
December 1, 2010
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
April 22, 2008
First Submitted That Met QC Criteria
April 23, 2008
First Posted (Estimate)
April 24, 2008
Study Record Updates
Last Update Posted (Estimate)
March 3, 2014
Last Update Submitted That Met QC Criteria
February 28, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- CR013048
- C-2006-007 (Other Identifier: Alza Corporation, DE, USA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.