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

NCT07088900 — Not applicable, Recruiting, 60 participants, Ain Shams University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07088900
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	60 (Estimated)
Sponsor	Ain Shams University (Other)
Conditions	Appendectomy, Pediatric
Interventions	caudal block using dexmedetomidine with bupivacaine, caudal block with bupivacaine (Procedure)
Dates	start 2025-08-01, primary completion 2026-06-30 (estimated), completion 2026-07-30 (estimated), first posted 2025-07-28, last updated 2026-05-06
Locations	1 site in Egypt

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Control Group	Active comparator	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.
Experimental Group	Experimental	Procedure: 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).

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).
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

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 2 Years to 7 Years

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.

+Locations (1)

Facility	City	Country	Status
Ain Shams university hospitals	Cairo	Egypt	Recruiting