Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Alza Corporation, DE, USA |
---|---|
Information provided by: | Alza Corporation, DE, USA |
ClinicalTrials.gov Identifier: | NCT00666393 |
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.
Condition | Intervention | Phase |
---|---|---|
Pediatrics Pain, Postoperative |
Drug: fentanyl iontophoretic transdermal system (40mcg) No placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 120 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
001: Experimental |
Drug: fentanyl iontophoretic transdermal system (40mcg) No placebo
40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
|
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.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email | info1@veritasmedicine.com |
France | |
Nantes, France, 44098 | |
Marseille, France, 13005 | |
Rennes, France, 35000 | |
Paris, France, 75015 | |
Paris, France, 75019 | |
Paris, France, 75012 | |
Norway | |
Bergen, Norway, 5021 | |
Oslo, Norway, 0027 | |
Oslo, Norway, 0407 | |
United Kingdom | |
London, United Kingdom, E1 1BB | |
Bristol, United Kingdom, BS2 8BJ | |
London, United Kingdom, WC1N 3JH | |
Nottingham, United Kingdom, NG7 2UH |
Study Director: | Alza Corporation Clinical Trial | Alza Corporation, DE, USA |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Director Clinical Development ) |
Study ID Numbers: | CR013048, C-2006-007 |
Study First Received: | April 22, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00666393 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pediatrics Analgesia, Patient-Controlled Opioids IONSYS™ Pain, Postoperative |
Anesthetics, Intravenous Fentanyl Adjuvants, Immunologic Anesthetics Central Nervous System Depressants Pain Narcotics |
Signs and Symptoms Postoperative Complications Anesthetics, General Analgesics Peripheral Nervous System Agents Analgesics, Opioid Pain, Postoperative |
Anesthetics, Intravenous Fentanyl Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pain Narcotics Pharmacologic Actions Adjuvants, Anesthesia Signs and Symptoms |
Pathologic Processes Postoperative Complications Anesthetics, General Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Pain, Postoperative |