Global assessment of treatment with IONSYS and its handling by patients, doctors and nursing staff in the management of acute moderate to severe post-surgery pain in hospitalised patients.

Phase 1

• Conditions: Acute, moderate to severe postoperative pain after elective surgery in a hospital setting in patients needing at least 24 hours strong opioids for pain therapy.; MedDRA version: 9.1Level: LLTClassification code 10054711Term: Postoperative pain

• Registration Number: EUCTR2005-004087-24-DE
• Lead Sponsor: JANSSEN-CILAG GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-10
• Study Completion: 2008-09-26
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Age 18 years or more; male or female
2. American Society of Anesthesiology (ASA) pre-operative physical status I, II or III
3. Expected hospitalization of at least 24 hours
4. Expected moderate to severe pain requiring treatment with parenteral opioids of
at least 24 hrs. following major elective surgery
5. Subject's capability to operate the iontophoretic transdermal system, under-
standing of the requirements of the clinical study and willingness to cooperate
6. Written Informed Consent, signed and dated during the pre-operative phase
7. Compliance with the following criteria in the recovery room after an elective
major surgery requiring a parenteral opioid treatment for at least 24 hours:
· General anesthesia
. Spinal anesthesia of = 4 h action time or
. Epidural anesthesia
. Epidural anesthesia
Epidural or local anesthesia: only when the administered analgesic was short-
lasting and given only for the period of surgery and not for the period in the
recovery room.
8. Alertness for at least 30 min. and spontaneous breathing in the recovery room
Respiratory rate: 10-24 breaths/minute; SpO2 90% or more [with or without
supplemental oxygen. Oxygen mask; max. CPAP)]; ability to answer questions
and follow commands
9. Pain score of = 4 out of 10 on a numerical rating scale (NRS) of titration to com-
fort. In the case of abdominal surgery, pain should be measured 5 minutes after
deep breathing and coughing.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Anamnestic allergy or hypersensitivity to:
·fentanyl
·and/or cetylpyridinium HCl
·and/or skin adhesives
2. Suspected or known dependence on strong opioids or a very high need for
strong opioids already existing prior to the start of the study
3. Psychological dependence on strong opioids before the start of the clinical study
4. Suspected or known abuse of any drug substance or alcohol
5. Chronic pain disorder
6. Active systemic or active topical skin disease that precludes application of the
iontophoretic transdermal system
7. Conditions associated with an increased risk of respiratory depression such as:
­ - Chronic obstructive pulmonary diseases or conditions causing a predisposition
for hypoventilation
- ­Head injuries, increased intracranial pressure, brain tumour, impaired
consciousness, or coma
8. Post-operative application of CNS active drugs that may increase the risk of re-
spiratory depression as a result of additive effects, but excluding:
­ - Anti-depressants/anxiolytics provided they are used for the same therapeutic
indication as in the time preceding the operation.
­ - Concomitant medication specified in section 3.3.5.
9. Severe hepatic or renal dysfunction
10. Women who are pregnant, breast feeding, or planning to breast feed within 24
hrs. of the last dose of study drug. Women of childbearing potential must pro-
duce a negative pregnancy test prior to admission. This does not apply to
women scheduled for a hysterectomy.
11. Participation in a previous clinical trial evaluating the transdermal PCA system, in
other clinical studies conducted in parallel and participation in a clinical study
within 30 days prior to enrolment in this clinical study
12. Post-operative pain during the first 24 hours that can usually be managed with
oral or non-opioid analgesia
13. Employees of the investigator or the institution who had direct involvement in
the study or other trials under the direction of the investigator/institution
14. Intra-operative administration of opioids other than morphine, fentanyl,
sulfetanil, alfentanil or remifentanil and piritramid as well as up to 50 mg
pethidine IV for shivering (only within 30 minutes after arrival in the recovery
room)
15. Very high need of opioids for pain control in the postoperative titration phase
(> 40 mg morphine iv or > 60 mg piritramide IV or equivalent dose of another
strong opioid)
16. Elapse of more than 6 hours since arrival in the recovery room before
reaching the pain level = 4
17. Probable Requirement of additional surgical procedures within 72 hours
18. Intubation and use of a laryngeal mask airway at the time of final screening
assessments

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Subject's overall assessment of pain treatment method of the last 24 hours.;Secondary Objective: - Subject´s, physician´s and staff´s global assessment at additional time-points<br>- Current pain intensity rating<br>- Number of hours per day with maintained comfort level (NRS*= 4)<br>- Evaluation of the post-operative progress of the patient every 24 hrs in regard of: <br> . time out of bed<br> . time to mobilisation <br>- Well beeing during the post-operative phase (PPP33®-questionaire) <br>- Physiotherapy ability <br>- Safety and tolerability of IONSYS as a hospital’s treatment option <br>- Comprehensibility of the information material;Primary end point(s): Subject's global assessment at 24 hours