The Effectiveness of Dexmedetomidine as an Adjuvant for Bupivacaine Caudal Block in Pediatric Open Appendectomy Under General Anesthesia

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-11-30

Brief Summary

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This study aims to evaluate if adding dexmedetomidine to bupivacaine in a caudal block can provide longer and better quality pain relief for children after open appendectomy surgery. The study will also assess the effect of this combination on the quality of recovery, including the incidence of emergence delirium, and its overall safety profile.

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Detailed Description

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Conditions

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Appendectomy Pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control Group

Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline.

Group Type ACTIVE_COMPARATOR

caudal block with bupivacaine

Intervention Type PROCEDURE

Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline

Experimental Group

Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 µg/kg of dexmedetomidine (diluted in 1 mL of normal saline).

Group Type EXPERIMENTAL

caudal block using dexmedetomidine with bupivacaine

Intervention Type PROCEDURE

Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 µg/kg of dexmedetomidine (diluted in 1 mL of normal saline).

Interventions

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caudal block using dexmedetomidine with bupivacaine

Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 µg/kg of dexmedetomidine (diluted in 1 mL of normal saline).

Intervention Type PROCEDURE

caudal block with bupivacaine

Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA (American Society of Anesthesiologists) physical status I or II.

Exclusion Criteria

* Refusal of participation by the legal guardian.
* Known allergy or hypersensitivity to local anesthetics or dexmedetomidine.
* Coagulation disorder or receiving anticoagulant therapy.
* Active infection at or near the injection site.
* Significant anatomical abnormalities of the lumbosacral spine.
* Pre-existing neurological disorders, psychiatric disorders, or a history of convulsions.
* Anticipated surgery time of more than 2.5 hours.
* Patients with severe asthma or active wheezing.

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No