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โ† Trials
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Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery

RecruitingPhase 4Ages 10 Years - 17 YearsAllPeking Union Medical College Hospital
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to see if a new pain medicine called Tegileridine is at least as effective as morphine (the standard treatment) for pain relief after spinal surgery in teenagers with scoliosis. This type of study is called a "non-inferiority" trial. The study will also carefully compare the safety of both medicines. The main questions it aims to answer are: Is Tegileridine no worse than morphine at controlling pain in the first 24 hours after surgery? How do the side effects (like sleepiness or nausea) of Tegileridine compare to those of morphine? Researchers will compare two different doses of Tegileridine against morphine. Neither the participants nor the doctors assessing them will know which medicine is being given. Participants in this study will: Receive one of the three pain medicine options through a pump (called a PCA pump) that they can control themselves

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Aged 10 years to less than 18 years. * Scheduled to undergo posterior spinal fusion (PSF) surgery for adolescent idiopathic scoliosis under general anesthesia. * American Society of Anesthesiologists (ASA) physical status classification I to III. * The participant and their parent or legal guardian voluntarily provide written informed consent prior to any study-related procedures. Exclusion Criteria: * Baseline room-air oxygen saturation (SpO2) \< 90% at rest, acute or severe bronchial asthma. * History of severe cardiovascular or cerebrovascular disease, such as myocardial infarction, unstable angina, second-degree or higher atrioventricular block, NYHA Class III or higher heart failure, or stroke. * Known or suspected gastrointestinal obstruction, including paralytic ileus. * Known hypersensitivity to opioids or any component of the study drug formulation. * Severe cognitive impairment or uncontrolled psychiatric disorders (e.g., active schizophrenia) that preclude the patient's ability to comprehend the NRS or independently operate the patient-controlled analgesia (PCA) pump. * Diagnosis of neuromuscular scoliosis or presence of any other chronic pain condition that may interfere with postoperative pain assessment. * Chronic use of opioid analgesics, or use of any long-acting analgesics within 48 hours prior to surgery (short-acting non-opioid analgesics are permitted but must be discontinued at least 12 hours preoperatively). * Planned postoperative admission to the intensive care unit (ICU).
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What it tests

  • Tegileridine
  • morphine
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Where

6 sites
Henan Provincial People's Hospital
Zhengzhou, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Beijing Chao-yang Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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