Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block

NCT07056244 | Recruiting

• 1 other identifier: soh-Med-25-6-13MS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

İnguinal Hernia

Outcome Measures

Primary Outcomes (1)

• duration of postoperative analgesia

  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.

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

Secondary Outcomes (1)

• 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"

Study Arms (2)

group A will receive Bupivacaine + Dexmedetomidine

ACTIVE COMPARATOR

Patients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexmedetomidine 1.5 mcg/kg for post operative analgesia.

Drug: Dexmedetomidine

group B will receive Bupivacaine + Dexamethasone

ACTIVE COMPARATOR

Patients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexamethasone 0.2 mg/kg for post operative analgesia.

Drug: Dexamethasone

Interventions

Dexmedetomidine DRUG

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

group A will receive Bupivacaine + Dexmedetomidine

Dexamethasone DRUG

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

group B will receive Bupivacaine + Dexamethasone

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2-6 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I and II.
• Scheduled for inguinal hernia surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Dexmedetomidine; Dexamethasone

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Reham R Younis, resident

CONTACT

01113405849; reham_ragab_post@med.sohag.edu.eg

Hala M Hashem, assistant professor

CONTACT

01004385249

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident-Anesthesia, ICU and pain management department-sohag hospital university

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: June 13, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

EG (1)