Pain, Postoperative Clinical Trial
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
Verified date | February 2014 |
Source | Alza Corporation, DE, USA |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 17 Years |
Eligibility |
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). |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alza Corporation, DE, USA |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Safety outcomes will be collected at intervals throughout the drug system application for a maximum of 72 hours. | Yes | |
Secondary | 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. | 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. | No |
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