Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07056244

Enrollment

Registered

2025-07-09

Start date

2025-06-13

Completion date

2025-12-15

Last updated

2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

İnguinal Hernia

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.

Interventions

DRUGDexmedetomidine

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

DRUGDexamethasone

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
duration of postoperative analgesia	Pain scores will be assessed at 15-minute intervals during the first two hours postoperatively, then at 4, 6, 8,12 and 24 hour	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

Measure	Time frame	Description
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	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

Countries

Egypt

Contacts

Primary ContactReham R Younis, resident

reham_ragab_post@med.sohag.edu.eg01113405849

Backup ContactHala M Hashem, assistant professor

01004385249

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026