EUCTR2014-002405-37-Outside-EU/EEA进行中（未招募）1 期
An open label evaluation of the safety and clinical utility of the active, separated system with enhanced controller (SSEC) fentanyl 40 mcg for the management of acute postoperative pain in pediatric patients 12 to less than 18 years of age.
Incline Therapeutics Inc, a wholly owned subsidiary of The Medicines Company0 个研究点目标入组 60 人开始时间: 2016年11月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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. Patients whose parent(s) or guardian(s) have/has signed and dated an informed consent form for the patient to participate in the study, or patients who have provided written assent to participate in the study.
- •2. Male or female inpatients, age 12 to < 18 years of age inclusive on the day of surgery
- •3. Patients capable of understanding and cooperating with the requirements of the study, including being able to report their pain intensity using the 11-point NRS and operate the SSEC.
- •4. American Society of Anesthesiologists (ASA) physical status I, II or III.
- •5. Body weight of at least 40.0 kg.
- •6. Postoperative patients who have undergone general or regional anaesthesia for abdominal, pelvic/genitourinary, orthopaedic, or thoracic surgery.
- •7. Postoperative patients who have been observed during recovery and are expected to remain hospitalized and have pain requiring parenteral opioids (i.e., IV PCA) for the next 24 hours or longer.
- •8. Patients who are awake and breathing spontaneously with a respiratory rate of 14 to 18 breaths per minute, SpO2 =93% (with or without supplemental oxygen), and able to answer questions and follow commands.
- •9. Patients who have been observed during recovery, who are awake, able to answer questions and follow commands, and who have been comfortable for at least 30 minutes with a pain intensity score = 4 (numeric rating scale 0–10), with or without titration to comfort with IV opioids.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Patients who have undergone any surgery on the airway, head, or neck.
- •2. Patients who received an extended-release opioid within 48 hours prior to Hour 0 or who are expected to have postoperative analgesia supplied by a continuous regional technique or patient-controlled epidural analgesia.
- •3. Patients with a history of allergy or hypersensitivity to fentanyl, skin adhesives, and/or cetylpyridinium chloride.
- •4. Patients who are expected to require intensive care or will likely require additional surgical procedures within 36 hours.
- •5. Patients who received intra-operative and/or postoperative administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil, or alfentanil. Exception: If there are no medical contraindications, meperidine (pethidine) up to 0.5 mg/kg IV is permitted during recovery for shivering.
- •6. Patients who require airway support (nasal or oropharyngeal airway intubation, or laryngeal mask airway [LMA]) at the time of final baseline assessments (i.e., at the time of IONSYS application [Hour 0]).
- •7. Patients who are known or suspected to be opioid tolerant, have a history of opioid dependence within 3 months before the start of the study, or who are known to have used illicit drugs or alcohol within 14 days of the start of the study.
- •8. Patients with active generalized skin disorders or active local skin disease that precludes SSEC application to the chest or upper arm.
- •9. Patients with any coexisting major medical conditions that are likely to interfere with study procedures including, but not limited to, psychiatric conditions, chronic depression, suicidal ideation, autism.
- •10. Positive pregnancy test for any female.
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