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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07088900

Enrollment

Registered

2025-07-28

Start date

2025-08-01

Completion date

2026-07-30

Last updated

2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendectomy, Pediatric

Keywords

caudal, dexmedetomidine, open appendectomy

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.

Interventions

PROCEDUREcaudal 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).

PROCEDUREcaudal 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 7 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to First Rescue Analgesia:	Up to 24 hours post-caudal block	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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026