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

The ability to mobilize was assessed through a combined analysis of participant's responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from not at all (score 0) to a very great deal (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility).

Time frame: Hour 72 or early study withdrawal

Population: The intention-to-treat (ITT) population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).

Antiemetic medicines are the drugs which prevent vomiting.

Time frame: Baseline up to end of study treatment (Hour 72)

Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).

Non-opioid analgesics are non morphine like medications used to get relieve from pain.

Time frame: Baseline up to end of study treatment (Hour 72)

Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).

Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group.

Time frame: Baseline up to Hour 3

Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).

The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?

Time frame: Hour 72 or early study withdrawal

Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.

Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from 'not at all' (Score 0) to 'a very great deal' (score 5). The total score was calculated as the mean of the non-missing items for all the questions.

Time frame: When participant was fit for discharge (FFD) (assessed up to 91 hours)

Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).

Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant's pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now.

Time frame: 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)

Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively.

Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a Yes or No basis. When all criteria were answered as Yes, participant was considered to be FFD.

Time frame: When participant was FFD (assessed up to 91 hours)

Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).

Technical failure was defined as malfunctioning or failure of device to work appropriately.

Time frame: Baseline up to end of study treatment (Hour 72)

Population: Safety population included all participants randomly assigned to study treatment and who used either of the study treatment at least once.

The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge.

Time frame: When participant was actually discharged from ward care (assessed up to 258.5 hours)

Population: The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours).