An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients
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ClinicalTrials.gov Identifier: NCT00666393 |
Recruitment Status :
Withdrawn
(Program Cancelled.)
First Posted : April 24, 2008
Last Update Posted : March 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain, Postoperative Pediatrics | Drug: fentanyl iontophoretic transdermal system (40mcg) No placebo Drug: fentanyl iontophoretic transdermal system (40mcg) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2008 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 001 |
Drug: fentanyl iontophoretic transdermal system (40mcg) No placebo
40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours Drug: fentanyl iontophoretic transdermal system (40mcg) 40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours |
- 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. [ Time Frame: Safety outcomes will be collected at intervals throughout the drug system application for a maximum of 72 hours. ]
- 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. [ Time Frame: 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. ]

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666393
Study Director: | Alza Corporation Clinical Trial | ALZA |
Responsible Party: | Alza Corporation, DE, USA |
ClinicalTrials.gov Identifier: | NCT00666393 |
Other Study ID Numbers: |
CR013048 C-2006-007 ( Other Identifier: Alza Corporation, DE, USA ) |
First Posted: | April 24, 2008 Key Record Dates |
Last Update Posted: | March 3, 2014 |
Last Verified: | February 2014 |
IONSYS™ Pain, Postoperative Analgesia, Patient-Controlled Opioids Pediatrics |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |