Cryptorchidism Clinical Trial
Official title:
Comparison of Analgesic Effect of Dexamethasone Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Orchiopexy
Single shot caudal epidural block is one of the most widespread technique for pediatric pain
management after infraumbilical surgical procedures.
However, in a significant proportion of patients, despite good initial analgesia from a
caudal block with local anesthetic, pain develops after the block resolves.
In order to decrease postoperative analgesic requirements after caudal block, various drugs
such as opioids, ketamine, clonidine, or dexmedetomidine to local anesthetics has been
investigated. However, their use has been limited by adverse effects in children.
Recently, many study suggested that epidurally administered dexamethasone could reduce the
incidence and severity of postoperative pain in adults. But there is no study concerning the
use of dexamethasone, as an adjuvant agent for the caudal epidural block in children.
The investigators performed prospective randomized double-blind study to examine the
analgesic effect of dexamethasone added to ropivacaine and ropivacaine alone in caudal
analgesia on postoperative pain control in pediatric patients undergoing orchiopexy.
80 children (aged 0.5-5 yr) undergoing day-case orchiopexy were included in this
prospective, randomized, double-blinded study. After inhalation induction of general
anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal
saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R ,
dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR. Postoperative pain
was recorded at 30min and 1,2,3 h by using Hospital of Eastern Ontario Pain Scale (CHEOPS,
0-10) and Faces Legs Activity Cry Consolability tool (FLACC, 0-10). Participants will be
followed for the duration of hospital stay, an expected average of 3 hours.
After discharge, rescue analgesic consumption, pain scores, and adverse effects were
evaluated for 24h.
The time to first supplemental oral analgesic medication demand was defined as the time from
the end of surgery to the first registration of a VAS ( 0-10) ≥ 5 by parent's observation.
Twenty-four hours after surgery, reports of delayed side effects and demands for rescue
analgesics from the child were gathered from parents via a telephone interview.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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