Comparación de fentanilo transdérmico y morfina intravenosa en analgesia controlada por el paciente para el control del dolor postoperatorio.

Phase 1

• Conditions: post-operative pain control; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2004-001201-10-ES
• Lead Sponsor: Janssen-Cilag EMEA Medical Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-04-24
• Study Start: 2012-03-20
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

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

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study:
1.Adult, age 18 or older, male or female;
2.American Society of Anesthesiology (ASA) pre-operative physical status I, II, or III (Attachment 2);
3.If the subject is female and of childbearing potential, she must have a negative pregnancy test after hospital admission, unless patient is undergoing hysterectomy;
4.Subjects, after an elective major abdominal or orthopaedic procedure, who are expected to have moderate or severe pain requiring parenteral opioids for at least 24 hours after surgery;
5.Subjects who are capable of understanding and cooperating with the requirements of the study and operating the Transdermal PCA system or the IV PCA device;
6.Subjects who have signed and dated an informed consent to participate in the study during the pre-operative assessment;
7.Subjects who have been admitted to the recovery room after general anesthesia, spinal anesthetic of < 4 hours duration of action or epidural anesthesia after an elective major abdominal or orthopaedic procedure and who expectedly suffer from moderate to severe pain and will require post-operative analgesia for at least 24 hours. Subjects with epidural or regional anesthesia will only be included if the provided analgesia was short lasting and was only given for the period of surgery and not for the period in the recovery room. When entering the recovery room, subjects with epidural or regional anesthesia must still qualify for needing IV PCA analgesia according to the local hospital standards;
8.Subjects who are alert and breathing spontaneously for at least 30 minutes in the waking room; respiratory rate 10 to 24 breaths per minute; SpO2 ³90% (with or without supplemental oxygen), subjects must be able to answer questions and follow commands;
9.Subjects with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS) after titration to comfort with IV morphine. In case of abdominal surgery, this should be measured five minutes after deep breathing and coughing;
10.Subjects who are expected to remain hospitalized for at least 24 hours post-operatively.
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 520
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
1.Subjects with a history of allergy or hypersensitivity to fentanyl and/or morphine and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride;
2.Subjects who are known or suspected to be strong opioid dependent, or who have a too high a need for strong opioids;
3.Subjects with a history of psychological opioid dependence before the start of the study, defined as meeting any of the criteria for substance dependence specified in Attachment 3;
4.Subjects who are known or suspected to have abused any drug substance or alcohol (see Attachment 4);
5.Subjects with chronic pain disorder (DSM-IV: F45.4);
6.Subjects with active systemic skin disease or active local skin disease that precludes Transdermal PCA system application;
7.Subjects known to have any of the following:
·severe chronic obstructive respiratory symptoms,
·susceptibility to present respiratory depression (possible synergistic effect associated with CNS drugs);
·subjects with renal dysfunction;
·subjects who have a coexisting medical condition, (possibly with chronic pain of another organ) that is likely to interfere with study procedures.
Remark:
- use of muscle relaxants is allowed;
- use of anti-depressants/anxiolytics is allowed provided that they were taken for the same indication before surgery;
8.Women who are pregnant, breast feeding, or planning to breast feed within 7 days of last dose of study drug;
9.Subjects who have taken any investigational drug or used an experimental medical device within 30 days before the start of the study or are currently enrolled in another investigational drug study;
10.Subjects who have previously enrolled in a Transdermal PCA study;
11.Subjects who have received peri-operative administration of opioids other than morphine, fentanyl, sufentanil, alfentanil or remifentanil.
Exception: If there are no medical contraindications, one dose of meperidine, up to 50 mg IV, is allowed within 30 minutes of arrival in the waking room for shivering;
12.Subjects who need very high doses of opioids to control their pain (more than 40 mg morphine/h) or more than 6 hours have elapsed since the subject arrived in the waking room;
13.Subjects whose post-operative pain would normally be managed with oral or non-opioid analgesia during the first 24 hours;
14.Subjects who are being treated in the intensive care unit;
15.Subjects who will probably require additional surgical procedures within 72 hours;
16.Subjects who are intubated or have a laryngeal mask airway (LMA) at the time of final screening assessments;
17.Subjects who are employees of the investigator or the institution who have direct involvement in the study or other trials under the direction of the investigator.

Study & Design

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