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.
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.
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.
Parallel
Oxycodone HCl
DrugAdminister oxycodone hydrochloride (0.1 mg/kg) intravenously half an hour before surgery.
Emergence agitation
The Pediatric Anesthesia Emergence Delirium (PAED) score is a standardized tool used to assess the presence and severity of emergence delirium (ED) in children following anesthesia. Emergence delirium is a post-anesthetic agitation or confusion commonly observed in young patients, characterized by behaviors such as crying, restlessness, and unresponsiveness. The PAED score evaluates these symptoms, helping clinicians gauge the need for interventions to manage postoperative agitation and ensure safe recovery. The PAED scale includes five behavioral items, each scored from 0 to 4, for a total score ranging from 0 to 20. A higher score indicates more severe agitation.
Postoperative pain score
The Face, Legs, Activity, Cry, Consolability (FLACC) score is a behavioral pain assessment tool commonly used to evaluate pain in children who are unable to communicate their pain verbally, including infants, young children, and those with cognitive impairments. The FLACC score is a reliable and widely used tool for assessing postoperative pain and discomfort in pediatric patients.
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Shantou University Medical College
Lead sponsor
Shenzhen Children's Hospital
Sponsor institution
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