Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair

June 10, 2014 updated by: Yonsei University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA status I-II,
  • children aged 2 to 6 yr
  • weight under 20kg
  • undergoing inguinal hernia repair

Exclusion Criteria:

  • Hypersensitivity fo any local anesthetics,
  • bleeding diathesis, infections at puncture sites,
  • pre-existing neurological disease,
  • patients taking Calcium channel block,
  • patients taking opioid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
normal saline 0.5ml
Drug: normal saline 0.5ml
Experimental: magnesum group
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.
Drug: caudal block
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of children who required analgesics
Time Frame: at 24 and 48 hours after surgery

Primary outcome is defined as the number of patients who required analgesics after discharge. Postoperative pain at home is assessed by parent using the PPPM scale that consists of 15 questions requiring a "yes" or "no" answer (yes = 1 point and no = 0 point). A PPPM score ≥ 6 by parent's observation is considered to represent clinically significant pain, requiring analgesics.

The PPPM is a 15-item observational checklist measure of pain intensity that was designed to be used by parents to support research and clinical postoperative care for children at home.
at 24 and 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

September 2, 2012

First Posted (Estimate)

September 6, 2012

Study Record Updates

Last Update Posted (Estimate)

June 12, 2014

Last Update Submitted That Met QC Criteria

June 10, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0278

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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