An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients

• Status: Withdrawn
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Fentanyl

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).