Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias
- Conditions
- Postoperative AnalgesiaS-ketaminePediatricsCaudal BlockHypospadias
- Interventions
- Registration Number
- NCT05922605
- Lead Sponsor
- Tao Zhang
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 44
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group E S-ketamine & Ropivacaine 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. Group C Ropivacaine The children are given 0.2%ropivacaine 0.7 ml／kg and saline of equal volume caudally.
- Primary Outcome Measures
Name Time Method duration of caudal analgesia 48 hours after the caudal injection Duration of analgesia is defined as the time from caudal injection to the first need for systemic analgesia.
- Secondary Outcome Measures
Name Time Method FLACC score 48 hours after the caudal block The Face, Legs, Activity, Cry, and Consolability (FLACC) scale
morphine consumption 48 hours after caudal block The Face, Legs, Activity, Cry, and Consolability (FLACC) scale at 1 hour (h), 3h,6h,12h,24h,48h or the time when children complain of pain after surgery. A score of more than 3 points is taken as an indication of inadequate analgesia and morphine 15ug/kg was administered .
complication 48 hours after the caudal block the incidence of residual motor block, urinary retention, paraesthesia; the incidence of respiratory depression ,vomiting ,nystagmus ,pruritus，odd behavior;.the sedation scores etc.
Trial Locations
- Locations (1)
First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China