Recruiting NCT07088900
The Effectiveness of Dexmedetomidine as an Adjuvant for Bupivacaine Caudal Block in Pediatric Open Appendectomy Under General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: caudal block using dexmedetomidine with bupivacaine, caudal block with bupivacaine.
- Who it may be relevant to
- Registry conditions: Appendectomy, Pediatric. Basic parameters: 2 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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). - 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
Primary outcome measures
- Time to First Rescue Analgesia: [Time frame: Up to 24 hours post-caudal block]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Ain Shams university hospitals — Cairo
Identifiers
NCT: NCT07088900 · FMASU MD352a/2023/2025