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Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery
Sponsor: Peking Union Medical College Hospital
Summary
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 after surgery. Use the pump for up to 48 hours. Regularly rate their pain levels using a simple number scale. Have their health closely monitored by the study team during this time.
Official title: Efficacy and Safety of Tegileridine for Postoperative Analgesia Following Adolescent Scoliosis Correction Surgery: A Prospective, Single-Center, Double-Blind, Non-Inferiority, Randomized Controlled Trial
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
171
Start Date
2026-01-01
Completion Date
2027-09-30
Last Updated
2025-11-17
Healthy Volunteers
No
Interventions
Tegileridine
Tegileridine is an investigational novel opioid receptor agonist. In this study, it is administered as an intravenous infusion via a patient-controlled analgesia (PCA) pump for postoperative pain management. The PCA solution is prepared by diluting Tegileridine injection in normal saline.
morphine
Morphine is a standard opioid analgesic used as the active comparator in this study. It is administered as an intravenous infusion via a patient-controlled analgesia (PCA) pump for postoperative pain management. The PCA solution is prepared by diluting Morphine injection in normal saline.
Locations (1)
Peking Union Medical College Hospital
Beijing, China