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

NCT06665048 | Not Yet Recruiting DMC

• 1 other identifier: szsetyyzjq@163.com
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Oxycodone; Analgesia, Postoperative

Keywords

anesthesia; Oxycodone; Analgesia, postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 30 minutes of emergencing

Secondary Outcomes (1)

• Postoperative pain score

  Within 30 minutes of emergencing

Study Arms (2)

Oxycodone group

EXPERIMENTAL

Administer oxycodone hydrochloride (0.1 mg/kg) intravenously half an hour before surgery.

Drug: Oxycodone HCl

Control group

NO INTERVENTION

The same routine anesthesia induction was given, and the same dose of normal saline was intravenously administered half an hour before the end of the operation to ensure that the operation conditions were the same as those of the control group except for the study drugs.

Interventions

Oxycodone HCl DRUG

Administer oxycodone hydrochloride (0.1 mg/kg) intravenously half an hour before surgery.

Oxycodone group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shantou University Medical College: lead

Study Sites (1)

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518000, China

Location

Related Publications (4)

• Li S, Xiong H, Jia Y, Li Z, Chen Y, Zhong L, Liu F, Qu S, Du Z, Wang Y, Huang S, Zhao Y, Liu J, Jiang L. Oxycodone vs. tramadol in postoperative parent-controlled intravenous analgesia in children: a prospective, randomized, double-blinded, multiple-center clinical trial. BMC Anesthesiol. 2023 May 3;23(1):152. doi: 10.1186/s12871-023-02054-8.

  PMID: 37138225 BACKGROUND

• Yang YT, Chen B, Bennett CL. FDA Approval of Extended-Release Oxycodone for Children With Severe Pain. Pediatrics. 2016 May;137(5):e20160205. doi: 10.1542/peds.2016-0205. Epub 2016 Apr 19. No abstract available.

  PMID: 27244829 BACKGROUND

• Rohmah I, Chen YC, Lin CJ, Tsao NH, Chiu HY. Diagnostic accuracy of the pediatric CAM-ICU, pre-school CAM-ICU, Pediatric Anesthesia Emergence Delirium and Cornell Assessment of Pediatric Delirium for detecting delirium in the pediatric intensive care unit: A systematic review and meta-analysis. Intensive Crit Care Nurs. 2024 Jun;82:103606. doi: 10.1016/j.iccn.2023.103606. Epub 2023 Dec 29.

  PMID: 38158251 BACKGROUND

• Wang Y, Chen L, Cui X, Zhou C, Zhou Q, Zhang Z. Clinical effect of minimally invasive surgery for inguinal cryptorchidism. BMC Surg. 2021 Jan 6;21(1):21. doi: 10.1186/s12893-020-01010-4.

  PMID: 33407324 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shenzhen Children's Hospital

Model Details: Two-arm study

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

CN (1)