Evaluating the Analgesic Efficacy of Oxycodone Hydrochloride in Pediatric Laparoscopic Cryptorchi… (NCT06665048) | Clinical Trial Compass
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Evaluating the Analgesic Efficacy of Oxycodone Hydrochloride in Pediatric Laparoscopic Cryptorchidism Surgery
China162 participantsStarted 2024-12-01
Plain-language summary
Cryptorchidism surgery is a common pediatric procedure, often performed laparoscopically to reposition undescended testes into the scrotum. This technique involves manipulation and traction of the spermatic cord, which can lead to emergence agitation and short-term postoperative pain. Managing these symptoms effectively is essential for enhancing perioperative comfort and supporting faster recovery in children.
Oxycodone hydrochloride, a newer opioid with established analgesic effects in adult surgery, has been less studied in pediatric contexts. This randomized controlled trial aims to evaluate the effects of administering 0.1 mg/kg oxycodone hydrochloride 30 minutes before the end of laparoscopic cryptorchidism surgery in children aged 1 to 6. The study will assess outcomes such as anesthesia emergence time, extubation time, incidence of emergence agitation, postoperative analgesia, and nausea and vomiting. The goal is to determine if oxycodone hydrochloride could be an effective choice for pain relief in pediatric laparoscopic surgery, potentially reducing pain and complications, and providing clinical evidence to optimize anesthesia management for safer and more satisfactory pediatric surgical care.
This research aspires to contribute to the guidelines for pediatric anesthesia, offering a scientific basis for the clinical application of oxycodone hydrochloride in children.
Who can participate
Age range
1 Year – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age range: patients between 1 and 6 years old who are scheduled to undergo cryptorchid surgery.
* No severe cardiopulmonary dysfunction, able to tolerate endotracheal intubation and general anesthesia.
* Children who have not received long-term analgesic medication before surgery.
* Children with a BMI range of 18.5-24 kg/m2.
Exclusion Criteria:
* History of allergy to oxycodone hydrochloride, fentanyl or other research-related drugs.
* Children who have severe pain or need long-term analgesic treatment.
* Combined with other serious diseases, such as malignant tumors, nervous system diseases, severe infections, coagulation disorders, congenital heart disease or other congenital malformations, and any other diseases that may interfere with the results of the study.
* Children who have received medication that may affect the evaluation of analgesic effects (such as other analgesics, sedatives, antidepressants, etc.) within two weeks before surgery.
* There are other situations that are not suitable for participation in this study, such as the child or family members cannot cooperate to complete the research requirements and may not be able to keep in touch during the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.