Actively Recruiting
The Effectiveness of Dexmedetomidine as an Adjuvant for Bupivacaine Caudal Block in Pediatric Open Appendectomy Under General Anesthesia
Led by Ain Shams University · Updated on 2026-05-06
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding dexmedetomidine to bupivacaine in a caudal block can provide longer and better pain relief for children aged 2 to 7 years undergoing open appendectomy surgery. The study also aims to assess the effect of this combination on recovery quality, including the rate of emergence delirium, as well as overall safety. Children in the study will be randomly assigned to one of two groups. One group will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline. The other group will receive a similar caudal block but with bupivacaine mixed with 1 g/kg of dexmedetomidine diluted in 1 mL of normal saline. All treatments are given under general anesthesia during the surgery. Participants will be monitored for up to 24 hours after the caudal block to measure the time until the first need for additional pain relief. Researchers will also observe recovery quality and any side effects. The study involves careful safety monitoring throughout the post-operative period to assess how well children recover and manage pain after surgery.
CONDITIONS
Brief Title
The Effectiveness of Dexmedetomidine as an Adjuvant for Bupivacaine Caudal Block in Pediatric Open Appendectomy Under General Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 7 years
- ASA physical status I or II
- Legal guardian provides written informed consent
You will not qualify if you...
- Refusal of participation by the legal guardian
- Known allergy or hypersensitivity to local anesthetics or dexmedetomidine
- Coagulation disorder or on anticoagulant therapy
- Active infection at or near the injection site
- Significant anatomical abnormalities of the lumbosacral spine
- Pre-existing neurological or psychiatric disorders, or history of convulsions
- Anticipated surgery time longer than 2.5 hours
- Severe asthma or active wheezing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to the day of surgery
Participants receive a single-shot caudal block with either bupivacaine mixed with dexmedetomidine or bupivacaine with normal saline during pediatric open appendectomy under general anesthesia.
1 visit (in-person) for the caudal block and surgery
Duration - Up to 24 hours post-caudal block
Participants are monitored for up to 24 hours after the caudal block to assess pain relief and need for rescue analgesia.
Approximately 1 follow-up visit or monitoring period
Trial Site Locations
Total: 1 location
1
Ain Shams university hospitals
Cairo, Egypt
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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