Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block

Not Applicable

Recruiting

• Conditions: İnguinal Hernia
• Interventions: Drug: Dexmedetomidine; Drug: Dexamethasone

• 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

Study Timeline

• Study Start: 2025-06-13
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-06-29
• Status Verified: 2025-07
• Study First Posted: 2025-07-09
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-30
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

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

Group	Intervention	Description
group A will receive Bupivacaine + Dexmedetomidine	Dexmedetomidine	Patients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexmedetomidine 1.5 mcg/kg for post operative analgesia.
group B will receive Bupivacaine + Dexamethasone	Dexamethasone	Patients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexamethasone 0.2 mg/kg for post operative analgesia.

Primary Outcome Measures

Name	Time	Method
duration of postoperative analgesia	"from time of caudal injection up to 24 hours post-operative"	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

Name	Time	Method
Pain score	''0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 4, 6, 8, 12, 24 hours post-operative''	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