Actively Recruiting
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block for Pediatrics Undergoing Inguinal Hernia Surgery: A Comparative Prospective Double-Blind Randomized Clinical Trial
Led by Sohag University · Updated on 2025-08-11
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two drugs, dexamethasone and dexmedetomidine, to see how well they work as additions to bupivacaine in a caudal epidural block for children aged 2 to 6 years undergoing inguinal hernia surgery. This prospective, randomized, double-blind study aims to evaluate postoperative pain relief in these pediatric patients. Participants are randomly assigned to one of two groups: one group receives bupivacaine 0.125% at 0.5 ml/kg combined with dexmedetomidine 1.5 mcg/kg, and the other group receives bupivacaine 0.125% at 0.5 ml/kg combined with dexamethasone 0.2 mg/kg. These treatments are given to manage pain after surgery. During the study, pain scores will be monitored at 15-minute intervals for the first two hours after surgery, then at 4, 6, 8, 12, and 24 hours. The main outcome measured is the duration of effective postoperative pain relief. The study is sponsored by Sohag University and expects to complete by December 2025.
CONDITIONS
Brief Title
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 6 years
- Both sexes
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for inguinal hernia surgery
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure on surgery day with monitoring up to 24 hours postoperatively
Participants receive a caudal epidural block with Bupivacaine combined with either Dexmedetomidine or Dexamethasone for postoperative pain relief after inguinal hernia surgery.
1 baseline visit (surgery day) and multiple assessments during the first 24 hours
Trial Site Locations
Total: 1 location
1
Sohag university Hospital
Sohag, Egypt
Actively Recruiting
Research Team
R
Reham R Younis, resident
H
Hala M Hashem, assistant professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Frequently Asked Questions
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