Dexmedetomidine versus dexamethasone added to bupivacaine for caudal epidural pain relief in children having inguinal hernia repair
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Sohag University Academic / other |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07056244 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Sohag
- Sohag university Hospital — Sohag, Egypt (Recruiting)
Study contacts
- Study coordinator: Reham R Younis, resident
- Email: reham_ragab_post@med.sohag.edu.eg
- Phone: 01113405849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.