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NCT Number: NCT07056244

Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block

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.

Recruiting

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Key information

Conditions

İnguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag university Hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Magdy M Amin, professor

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

Dexamethasone

Drug

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

Primary outcomes

  1. duration of postoperative analgesia

    Time frame: "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 outcomes

  1. Pain score

    Time frame: "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

Study contacts

Contact information is provided by the study sponsor or research team.

Hala M Hashem, assistant professor

CONTACT

01004385249

Reham R Younis, resident

CONTACT

[email protected]

01113405849

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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