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

NCT07088900 | Recruiting DMC

• 1 other identifier: FMASU MD352a/2023/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appendectomy; Pediatric

Keywords

caudal; dexmedetomidine; open appendectomy

Outcome Measures

Primary Outcomes (1)

• Time to First Rescue Analgesia:

  Defined as the time interval in minutes from the performance of the caudal block until the first administration of rescue analgesia (ibuprofen), which is prompted by a FLACC pain score of ≥ 4.

  Up to 24 hours post-caudal block

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Procedure: caudal block with bupivacaine

Experimental Group

EXPERIMENTAL

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).

Procedure: caudal block using dexmedetomidine with bupivacaine

Interventions

caudal block using dexmedetomidine with bupivacaine 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).

Experimental Group

caudal block with bupivacaine PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

EG (1)