Inguinal Hernia Clinical Trial
A caudal anesthesia is one of the most commonly used technique providing intra and
postoperative analgesia in pediatric low abdominal surgery. The practice of adding adjunct
analgesic drugs to local anesthetics for caudal block is common. The most commonly used
drugs are opioids, clonidine, and ketamine. However, their use has been limited by adverse
effects in children.
Recently, the importance of magnesium in analgesic effects has been increased. Magnesium is
the fourth most abundant cation in the body. It has antinociceptive effects in human and
these effects are primarily based on the regulation of calcium influx into the cell.
Magnesium is a physiological calcium antagonist and blocks N-methyl-D-aspartate (NMDA)
receptor and such NMDA antagonism prevents the central sensitization from nociceptive
stimulation. Many study suggested that epidurally administered magnesium could reduce the
postoperative pain in adults. But few studies are available about the use of magnesium in
pediatrics.
The investigators performed prospective randomized double-blind study to examine the
analgesic effect of magnesium added to ropivacaine and ropivacaine alone in caudal analgesia
on postoperative pain control in pediatric patients undergoing inguinal hernia repair.
80 children (aged 2- 6 yr) undergoing inguinal hernia repair 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 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium
50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR. 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 (Parents Postoperative Pain
Measurement, PPPM), and adverse effects were evaluated for 48h.
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 PPPM( 0 - 15) ≥ 6 by parent's observation.
48 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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