Using S-ketamine to enhance pain relief in children after hypospadias surgery
Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias
This study is testing if adding S-ketamine to a pain medication can help children feel less pain for longer after hypospadias surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 3 Months to 18 Years |
| Sex | Male |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05922605 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of S-ketamine as an additive to ropivacaine for caudal analgesia in children undergoing hypospadias surgery. Forty-four children will be randomly assigned to receive either a combination of ropivacaine and S-ketamine or ropivacaine with saline. The study will monitor postoperative pain levels using a standardized scoring system at various intervals. The goal is to determine if S-ketamine can prolong the duration of pain relief compared to ropivacaine alone.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 months to 18 years, weighing less than 28 kg, and scheduled for elective hypospadias surgery.
Not a fit: Patients with congenital abnormalities of the lower spine, hypersensitivity to local anesthetics, or preexisting neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide longer-lasting pain relief for children undergoing surgery, reducing the need for additional pain medications.
How similar studies have performed: Previous studies have shown that ketamine can enhance analgesia when used as an additive, but the specific use of S-ketamine in this context is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients who have congenital abnormalities of lower spine and meninges. * Patients with hypersensitivity to any local anesthetics * Children with coagulation disorders * Presence of Infections at puncture sites * Preexisting neurological disease * Refusal to consent by parent/guardian
Where this trial is running
Guangzhou, Guangdong
- First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: tao Zhang, MD
- Email: zhtao98@aliyun.com
- Phone: 8613580482938
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.