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

NCT00666393 | Withdrawn Phase 3

• 2 other identifiers: CR013048C-2006-007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative; Pediatrics

Keywords

IONSYS™; Pain, Postoperative; Analgesia, Patient-Controlled; Opioids; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (1)

001

EXPERIMENTAL

Drug: fentanyl iontophoretic transdermal system (40mcg) No placebo; Drug: fentanyl iontophoretic transdermal system (40mcg)

Interventions

fentanyl iontophoretic transdermal system (40mcg) No placebo DRUG

40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours

001

fentanyl iontophoretic transdermal system (40mcg) DRUG

40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours

001

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Alza Corporation Clinical Trial

  ALZA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 3, 2014

Record last verified: 2014-02