Dexmedetomidine versus dexamethasone added to bupivacaine for caudal epidural pain relief in children having inguinal hernia repair
Official title: 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
Run by Sohag University · NCT07056244 · Data updated 2026-11-12
This will test whether adding dexmedetomidine or dexamethasone to bupivacaine gives better pain relief for children aged 2–6 having inguinal hernia surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 6 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Status | Recruiting |
| Started | June 13, 2025 |
| Main results expected | December 15, 2025 |
| Study ends | December 15, 2025 |
| Registry record updated | August 11, 2025 |
| Trial ID | NCT07056244 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 2–6 years with ASA physical status I or II who are scheduled for inguinal hernia repair at Sohag University Hospital and whose parents provide consent are ideal candidates.
✕Probably not a fit
Children with sacral anatomic abnormalities, local infection at the injection site, coagulopathy, known hypersensitivity to the study drugs, neurologic disease, developmental delay, or those outside the 2–6 year age range are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, double-blind comparison of two adjuvants added to 0.125% bupivacaine delivered via caudal epidural in children aged 2–6 undergoing inguinal hernia repair. Eligible children (ASA I–II) are randomized to receive either dexmedetomidine or dexamethasone with the local anesthetic, with clinicians and outcome assessors blinded to group assignment. Outcomes will include duration of postoperative analgesia, pain scores, need for rescue analgesics, and monitoring for hemodynamic or neurologic adverse effects. Standard perioperative care is provided at Sohag University Hospital with predefined exclusions such as sacral anomalies, local infection, coagulopathy, known drug allergy, or neurologic disease.
Why it matters
Potential benefit: If successful, one adjuvant could extend postoperative pain relief and reduce the need for additional pain medicines in young children.
How similar studies have gone: Previous adult and pediatric regional anesthesia reports have shown that both dexmedetomidine and dexamethasone can prolong neuraxial and peripheral block duration, but direct head-to-head data in pediatric caudal blocks remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Sohag university Hospital
Sohag, Egypt Recruiting
Study contacts
- Study coordinator: Reham R Younis, resident
- Email: reham_ragab_post@med.sohag.edu.eg
- Phone: 01113405849
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.