MedPath

Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block

Not Applicable
Recruiting
Conditions
İnguinal Hernia
Interventions
Registration Number
NCT07056244
Lead Sponsor
Sohag University
Brief Summary

The goal of This prospective, randomized, double-blind comparative study is to compare the efficacy of dexamethasone and dexmedetomidine as adjuvants to bupivacaine 0.125% in caudal epidural block for pediatrics undergoing inguinal hernia surgery, aged 2-6 years.

of Both sex.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
80
Inclusion Criteria
  • Children aged 2-6 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I and II.
  • Scheduled for inguinal hernia surgery
Exclusion Criteria
  • Parents or legal guardians refusal.
  • Known hypersensitivity to any study drugs.
  • Abnormal sacral anatomy
  • Local infection at the injection site.
  • Neurological disease.
  • Coagulopathy.
  • Mental retardation.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
group A will receive Bupivacaine + DexmedetomidineDexmedetomidinePatients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexmedetomidine 1.5 mcg/kg for post operative analgesia.
group B will receive Bupivacaine + DexamethasoneDexamethasonePatients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexamethasone 0.2 mg/kg for post operative analgesia.
Primary Outcome Measures
NameTimeMethod
duration of postoperative analgesia"Pain scores will be assessed at 15-minute intervals during the first two hours postoperatively, then at 4, 6, 8,12 and 24 hour"

FLACC scale (Face, Leg, Activity, Crying, Consolability) total score of 0-10 ,so the duration of analgesia will be defined as the time from caudal injection to the point when FLACC score exceeds 4.

Secondary Outcome Measures
NameTimeMethod
Pain score"Pain scores will be assessed at 15-minute intervals during the first two hours postoperatively, then at 4, 6, 8,12 and 24 hour"

Postoperative pain will be evaluated using the FLACC scale (Face, Leg, Activity, Crying, Consolability). Pain scores will be assessed at 15-minute intervals during the first two hours postoperatively, then at 4, 6, 8,12 and 24 hour. The duration of analgesia will be defined as the time from caudal injection to the point when FLACC score exceeds 4, at which time rescue analgesia is needed

Trial Locations

Locations (1)

Sohag university Hospital

🇪🇬

Sohag, Egypt

Sohag university Hospital
🇪🇬Sohag, Egypt
Magdy M Amin, professor
Contact

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.