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

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 3 months
Maximum Age: 18
Healthy Volunteers: f
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• informed parent consent, ASA I or II children, between 3months and 18 years of age,and weighing \<28kg, scheduled for elective hypospadias surgery with general anesthesia will be recruited.

Locations
Other Locations
China
First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
tao Zhang, MD
zhtao98@aliyun.com
8613580482938
Backup
weiyi Xu, B.M
xuweiyi75@foxmail.com
8619875691896
Time Frame
Start Date: 2023-06-20
Completion Date: 2025-05-01
Participants
Target number of participants: 44
Treatments
Experimental: Group E
the children are given a mixture of 0.2%ropivacaine 0.7 ml/kg and preservative-free S-ketamine 0.5 mg/kg for caudal analgesia.
Active_comparator: Group C
The children are given 0.2%ropivacaine 0.7 ml/kg and saline of equal volume caudally.
Related Therapeutic Areas
Sponsors
Leads: Tao Zhang

This content was sourced from clinicaltrials.gov