Comparative Evaluation of dexmedetomidine versus dexamethasone as an adjuvant to bupivacaine in bilateral suprazygomatic maxillary nerve block for postoperative analgesia in children undergoing cleft palate surgeries : A Randomized, Prospective, Double-Blind Study
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- AIIMS New Delhi
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Time for first rescue analgesia
Overview
Brief Summary
This study is a randomized, prospective, double-blind clinical trial designed to compare the effectiveness of dexmedetomidine and dexamethasone as adjuvants to bupivacaine in bilateral suprazygomatic maxillary nerve blocks for providing postoperative analgesia in children undergoing cleft palate surgery. The aim is to evaluate which adjuvant offers superior pain relief, longer duration of analgesia, and better safety profile in the pediatric population, thereby contributing to improved postoperative outcomes and reduced need for systemic analgesics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 8.00 Month(s) to 5.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children posted for elective cleft palate repair under general anaesthesia Aged between 8 months to 5 years ASA category I and II Willing to give consent.
Exclusion Criteria
- •Lack of Parental consent Allergic to local anesthetics Coagulation disorders Local infection or lesion at the proposed puncture site Language difficulties Cognitive disorders Comorbid conditions like congenital heart diseases airway obstruction disease and central nervous system disorders.
Outcomes
Primary Outcomes
Time for first rescue analgesia
Time Frame: Time for first rescue analgesia 24 hours | duration of analgesia 24 hours
Duration of analgesia
Time Frame: Time for first rescue analgesia 24 hours | duration of analgesia 24 hours
Secondary Outcomes
- Postoperative FLACC score(Total Postoperative fentanyl consumption)
Investigators
Amanpreet Singh
AIIMS New Delhi