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NCT Number: NCT07088900

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

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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Key information

Conditions

Appendectomy Pediatric

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Time to First Rescue Analgesia:

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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