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

NCT ID: NCT00666393

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-12-31

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, 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with the combined use of fentanyl HCl 40 mcg system and the use of supplemental analgesia, the patient may be withdrawn from the study.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.

Conditions

Pain, Postoperative; Pediatrics

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

001

Group Type: EXPERIMENTAL

fentanyl iontophoretic transdermal system (40mcg) No placebo

Intervention Type: DRUG

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

fentanyl iontophoretic transdermal system (40mcg)

Intervention Type: DRUG

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

Interventions

fentanyl iontophoretic transdermal system (40mcg) No placebo

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

Intervention Type: DRUG

fentanyl iontophoretic transdermal system (40mcg)

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

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alza Corporation, DE, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alza Corporation Clinical Trial

Role: STUDY_DIRECTOR

ALZA

Other Identifiers

C-2006-007

Identifier Type: OTHER

Identifier Source: secondary_id

CR013048

Identifier Type: -

Identifier Source: org_study_id