Clinical trial NCT00766506: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: IONSYS
Fentanyl
Morphine
PCA
Postoperative pain
Mobilization
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2008-10-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria

* Participants, after an elective major abdominal or orthopedic (pertaining to bones) surgery
* 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 dependent
* 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

Primary outcomes:
measure: Participant's Evaluation of Mean Ability to Mobilize After Surgery
timeFrame: Hour 72 or early study withdrawal
Secondary outcomes:
measure: Pain Intensity Numerical Rating Scale (NRS)
timeFrame: Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours)
measure: Nurse Ease of Care (EOC) Questionnaire Score
timeFrame: When participant was fit for discharge (FFD) (assessed up to 91 hours)
measure: Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control
timeFrame: Hour 72 or early study withdrawal
measure: Time to Fit For Discharge (FFD)
timeFrame: When participant was FFD (assessed up to 91 hours)
measure: Number of Participants Who Require Rescue Medication
timeFrame: Baseline up to Hour 3
measure: Number of Participants Who Require Concomitant Antiemetic Medication
timeFrame: Baseline up to end of study treatment (Hour 72)
measure: Number of Participants Who Require Concomitant Non-opioid Analgesics
timeFrame: Baseline up to end of study treatment (Hour 72)
Other outcomes:
measure: Time to Actual Discharge
timeFrame: When participant was actually discharged from ward care (assessed up to 258.5 hours)
measure: Number of Participants Facing Technical Failure of the Device
timeFrame: Baseline up to end of study treatment (Hour 72)
Locations:
city: Belfast
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Salford
country: United Kingdom
city: Solihull
country: United Kingdom
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: