NCT05922605

Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Tao Zhang · Academic / Other
• Sex: Male
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious. Ketamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of S-ketamine, the S(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. In this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of S-ketamine as additive on the duration of caudal analgesia.

Detailed description

Forty-four children scheduled for hypospadias randomize into 2 groups. Group E (n=22) (0.2% ropivacaine 0.7 ml／kg and S-ketamine 0.5 mg/kg), group C(n=22)( 0.2%ropivacaine 0.7ml／kg and equivalent saline) intraoperative and postoperative hemodynamics will be recorded. Postoperative pain is assessed using an established 6-item FLACC score at 1h,3h,6h,12h,24h,48h, or the time when children complain of pain after surgery. A score of more15μg/kg is administered.Investigators propose to compare the duration of caudal analgesia provided by plain ropivacaine and by a mixture of ropivacaine and S-ketamine.

Conditions

• Postoperative Analgesia
• S-ketamine
• Pediatrics
• Caudal Block
• Hypospadias

Interventions

Type	Name	Description
DRUG	S-ketamine & Ropivacaine	The experiment group (Group E) will receive a mixture of ropivacaine 0.2% 0.7 ml／kg and preservative-free S-ketamine 0.5 mg/kg caudally for postoperative analgesia.
DRUG	Ropivacaine	The experiment group (Group C) will receive ropivacaine 0.2% 0.7 ml／kg plain and equial volume saline caudally for postoperative analgesia.

Timeline

• Start date: 2023-06-20
• Primary completion: 2025-04-30
• Completion: 2025-05-01
• First posted: 2023-06-28
• Last updated: 2023-10-30

Locations

1 site across 1 country: China