Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block

NCT ID: NCT07056244

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2025-12-15

Brief Summary

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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

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Conditions

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İnguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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group A will receive Bupivacaine + Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

group B will receive Bupivacaine + Dexamethasone

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

Interventions

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Dexmedetomidine

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

Intervention Type DRUG

Dexamethasone

as adjuvant to bupivacaine in caudal epidural block for postoperative analgesia

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Reham Ragab Younis

Resident-Anesthesia, ICU and pain management department-sohag hospital university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Reham R Younis, resident

Role: CONTACT

01113405849

Hala M Hashem, assistant professor

Role: CONTACT

01004385249

Facility Contacts

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Magdy M Amin, professor

Role: primary

Other Identifiers

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soh-Med-25-6-13MS

Identifier Type: -

Identifier Source: org_study_id

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