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An Efficacy and Safety Study to Compare Fentanyl Ionsys and Routine Care With Intravenous (IV) Morphine Patient-controlled Analgesia (PCA) in Participants Who Have Undergone Elective Major Abdominal or Orthopedic Surgery

Information source: Janssen-Cilag Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain, Postoperative

Intervention: Fentanyl IONSYS (Device); Morphine IV PCA (Device)

Phase: Phase 4

Status: Terminated

Sponsored by: Janssen-Cilag Ltd.

Official(s) and/or principal investigator(s):
Janssen-Cilag Ltd. Clinical Trial, Study Director, Affiliation: Janssen-Cilag Ltd.


The purpose of this study is to evaluate the mobilization characteristics, clinical use, safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) and morphine intravenous (IV) PCA for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective major abdominal or orthopedic (pertaining to the bones) surgery.

Clinical Details

Official title: Comparison of Ionsys and Routine Care With Morphine IV (Intravenous) PCA in the Management of Early Post-operative Mobilisation, Ability to Mobilise and in Time to Fitness For Discharge

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Participant's Evaluation of Mean Ability to Mobilize After Surgery

Secondary outcome:

Pain Intensity Numerical Rating Scale (NRS)

Nurse Ease of Care (EOC) Questionnaire Score

Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control

Time to Fit For Discharge (FFD)

Number of Participants Who Require Rescue Medication

Number of Participants Who Require Concomitant Antiemetic Medication

Number of Participants Who Require Concomitant Non-opioid Analgesics

Detailed description: This is a randomized (study drug assigned by chance), multicentre (when more than one hospital or medical school team work on a medical research study), open-label (participants and physicians are told which treatment the participants are receiving), active-controlled (experimental treatment is compared to a standard treatment), parallel group study (a study comparing the response in two or more groups of participants receiving different treatments). The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. Eligible participants (who require pain treatment with strong opioids [morphine like medications] for at least 24 hours after an elective spine or elective orthopedic surgery) will be randomly assigned to receive either Ionsys or morphine IV PCA. Participants' safety will be monitored.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria

- Participants, after an elective major abdominal or orthopedic (pertaining to bones)


- Expected to have acute (a quick and severe form of illness in its early stage)

moderate (medium level of seriousness) to severe (very serious) post-operative pain requiring parenteral (administration by injection) opioids (morphine like medication) for at least 24 hours after surgery

- Participants who have undergone General anesthesia (loss of sensation or feeling),

spinal anesthesia of less than or equal to 4 hours duration or epidural (outside the spinal cord) anesthesia

- Participants with respiratory rate 10 to 24 breaths per minute

- Participants with a pain score less than or equal to 4 out of 10 on a Numerical

Rating Scale (NRS), after titration to comfort with intravenous (IV) morphine Exclusion Criteria

- Surgery secondary to malignancy (cancer or other progressively enlarging and

spreading tumor) or trauma (injury)

- History of psychological opioid dependence and/or known or suspected to be opioid


- Severe chronic (lasting a long time) obstructive respiratory symptoms susceptibility

to respiratory depression, moderate to severe renal (having to do with the kidney) dysfunction

- Peri-operative administration of opioids other than morphine, fentanyl, sufentanil,

alfentanil or remifentanil

- Require high doses of opioids to control their pain (more than 40 milligram morphine

IV) during titration to comfort, or more than 6 hours have elapsed since the participant arrived in the recovery room or Monoamine oxidase inhibitors (MAOI) within 14 days pre-study

Locations and Contacts

Belfast, United Kingdom

Cardiff, United Kingdom

Edinburgh, United Kingdom

Glasgow, United Kingdom

Liverpool, United Kingdom

Salford, United Kingdom

Solihull, United Kingdom

Additional Information

Comparison of Ionsys and routine care with morphine IV PCA in the management of early post-operative mobilisation, ability to mobilise and in time to Fitness For Discharge.

Starting date: May 2008
Last updated: March 14, 2013

Page last updated: August 23, 2015

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