Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- duration of caudal analgesia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The Patients allocated to study groups using computer generates random list & group assignment is sealed in sequentially numbered opaque envelopes that open after induction of anesthesia.
Eligibility Criteria
- Ages
- 3 Months to 18 Years (Child, Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: S-ketamine & Ropivacaine (Drug)
Group C
The children are given 0.2%ropivacaine 0.7 ml／kg and saline of equal volume caudally.
Intervention: Ropivacaine (Drug)
Outcomes
Primary Outcomes
duration of caudal analgesia
Time Frame: 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 Outcomes
- FLACC score(48 hours after the caudal block)
- morphine consumption(48 hours after caudal block)
- complication(48 hours after the caudal block)
Investigators
Tao Zhang
Associate Professor
First Affiliated Hospital, Sun Yat-Sen University