Role of Adding Dexmedetomidine, Ketamine and Magnesium Sulphate to Caudal Block as Preemptive Analgesia in Hypospadias Repair in Pediatrics: a Randomized Double-blinded Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Kafrelsheikh University
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- First time of rescue analgesia requirement
Study Overview
Brief Summary
Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 1 Year to 7 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 1-7 years
- •American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair.
Exclusion Criteria
- •Developmental delay
- •Psychological or neurological disorders
- •Difficult airway
- •Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).
Arms & Interventions
Dexmedetomidine
0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
Intervention: Dexmedetomidine (Drug)
Ketamine
0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally
Intervention: Ketamine (Drug)
Magnesium sulphate
0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.
Intervention: Magnesium sulphate (Drug)
Outcomes
Primary Outcomes
First time of rescue analgesia requirement
Time Frame: 24 hours postoperatively
If the FLACC score is ≥ 4, pethidine 1 mg/kg. The first time to require analgesia will be calculated (the time from caudal block to the first time to pethidine injection).
Secondary Outcomes
- The incidence of adverse effects(24 hours postoperatively)
- Pain score(24 hours postoperatively)
- Total consumption of rescue analgesia(24 hours postoperatively)
Investigators
Gamal Hendawy Shams
Lecturer
Kafrelsheikh University