EUCTR2005-004087-24-DE进行中（未招募）1 期
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.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •1. Anamnestic allergy or hypersensitivity to:
- •·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
- •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
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