A Phase 4 interventional study of S-ketamine & Ropivacaine and Ropivacaine in Postoperative Analgesia, S-ketamine and Pediatrics, sponsored by Tao Zhang. Recruiting at 1 site in China. Open to male participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Tao Zhang · Phase 4, Interventional, and Treatment
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.
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.
131 studies on the registry are indexed under Hypospadias; 34 are open to participants now.
This study's planned enrollment of 44 is below the median of 68 across 102 interventional studies indexed under Hypospadias.
Browse Hypospadias studies →Tao Zhang is the lead sponsor of 16 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: S-ketamine & Ropivacaine
The children are given 0.2%ropivacaine 0.7 ml／kg and saline of equal volume caudally.
Drug: 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.
The experiment group (Group C) will receive ropivacaine 0.2% 0.7 ml／kg plain and equial volume saline caudally for postoperative analgesia.
duration of caudal analgesia
Duration of analgesia is defined as the time from caudal injection to the first need for systemic analgesia.
Time frame: 48 hours after the caudal injection
morphine consumption
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 .
Time frame: 48 hours after caudal block
FLACC score
The Face, Legs, Activity, Cry, and Consolability (FLACC) scale
Time frame: 48 hours after the caudal block
complication
the incidence of residual motor block, urinary retention, paraesthesia; the incidence of respiratory depression ,vomiting ,nystagmus ,pruritus，odd behavior;.the sedation scores etc.
Time frame: 48 hours after the caudal block
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tao Zhang