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

Ain Shams University

Status: Enrolling

Conditions: Pediatric; Appendectomy

Treatments: Procedure: caudal block with bupivacaine; Procedure: caudal block using dexmedetomidine with bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07088900

FMASU MD352a/2023/2025

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

inclusion criteria:

• ASA (American Society of Anesthesiologists) physical status I or II.
• Legal guardian provides written informed consent. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Procedure: caudal block with bupivacaine

Experimental Group

Experimental group

Description:

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).

Treatment:

Procedure: caudal block using dexmedetomidine with bupivacaine