Status:
WITHDRAWN
An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Pain, Postoperative
Pediatrics
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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, pati...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00666393
Start Date
October 1 2008
End Date
December 1 2010
Last Update
March 3 2014
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