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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-7
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Legal guardian provides written informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • caudal block using dexmedetomidine with bupivacaine

    Procedure/Surgery

    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/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to 24 hours post-caudal block

Secondary outcomes

Other outcomes

Sponsors and contacts

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