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

Alza Corporation

Status and phase

Withdrawn

Phase 3

Conditions

Pediatrics

Pain, Postoperative

Treatments

Drug: fentanyl iontophoretic transdermal system (40mcg)

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00666393

CR013048

C-2006-007 (Other Identifier)

Details and patient eligibility

About

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.

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with the combined use of fentanyl HCl 40 mcg system and the use of supplemental analgesia, the patient may be withdrawn from the study.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

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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).