An Open-Label Evaluation of Safety of the Fentanyl Iontophoretic Transdermal System (40mcg) for Management of Acute Post-Operative Pain in Pediatric Patients

Condition(s) targeted: Pediatrics; Pain, Postoperative

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

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Alza Corporation, DE, USA

Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA

Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

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.

Official title: An Open-Label Evaluation of Safety of the IONSYS™ System [Fentanyl Iontophoretic Transdermal System (40ug) for Management of Acute Post-Operative Pain in Pediatric Patients

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: 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.

Secondary outcome: 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.

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.

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

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)

This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

Nantes 44098, France

Marseille 13005, France

Rennes 35000, France

Paris 75012, France

Paris 75019, France

Paris 75015, France

Bergen 5021, Norway

Oslo 0027, Norway

Oslo 0407, Norway

London E1 1BB, United Kingdom

Nottingham NG7 2UH, United Kingdom

London WC1N 3JH, United Kingdom

Bristol BS2 8BJ, United Kingdom

Ending date: October 2010
Last updated: November 20, 2008