Caudal Block, Hypospadias, Pediatrics, Postoperative Analgesia, S-ketamine
Conditions
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.
Interventions
DRUGS-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.
DRUGRopivacaine
The experiment group (Group C) will receive ropivacaine 0.2% 0.7 ml／kg plain and equial volume saline caudally for postoperative analgesia.
Sponsors
Tao Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
MALE
Age
3 Months to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
| FLACC score | 48 hours after the caudal block | The Face, Legs, Activity, Cry, and Consolability (FLACC) scale |
| 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. |
Countries
China
Contacts
Primary Contacttao Zhang, MD
Backup Contactweiyi Xu, B.M
Outcome results
None listed