The Effectiveness of Dexmedetomidine as an Adjuvant for Bupivacaine Caudal Block in Pediatric Open Appendectomy Under General Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Time to First Rescue Analgesia:
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control Group
Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline.
Intervention: caudal block with bupivacaine (Procedure)
Experimental Group
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).
Intervention: caudal block using dexmedetomidine with bupivacaine (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohamed Tarek Hussein
doctor
Ain Shams University