Evaluating the Analgesic Efficacy of Oxycodone Hydrochloride in Pediatric Laparoscopic Cryptorchidism Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorShantou University Medical College

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Oxycodone HCl

Treatment groups

162 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shantou University Medical College

Lead sponsor

Shenzhen Children's Hospital

Sponsor institution