Comparison of caudal bupivacaine and dexmedetomidine with caudal bupivacaine and intravenous dexmedetomidine for post operative analgesia in children.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- To compare caudal and intravenous dexmedetomidine for prolongation of post operative analgesia in children undergoing elective surgeries using FLACC scale
Study Overview
Brief Summary
This study is randomized participant blinded parallel group study comparing two groups of 48 children each undergoing elective surgeries. One group is given caudal bupivacaine and caudal dexmedetomidine and other group is given caudal bupivacaine and intravenous dexmedetomidine .The study will be conducted in VMMC and Safdarjung Hospital,New Delhi . The primary objective of the study is post operative analgesia in children undergoing elective surgeries using FLACC scale and secondary objective of the study is intraoperative haemodynamic effects and sedation with dexmedetomidine given through caudal or intravenous route.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •American society of Anaesthesiologists physical status I-II Age 1 to 8 year old children.
- •Scheduled for elective surgery.
Exclusion Criteria
- •Infection at the site of block.
- •Coagulopathy.
- •Pre-existing neurological or spinal disease and abnormalities of the sacrum.
- •Allergy to local anaesthetics.
Outcomes
Primary Outcomes
To compare caudal and intravenous dexmedetomidine for prolongation of post operative analgesia in children undergoing elective surgeries using FLACC scale
Time Frame: Measuring post operative analgesia using FLACC score and Ramsay sedation score at 1 2 4 8 12 24hrs after surgery
Secondary Outcomes
- To compare the intra operative haemodynamic effects and sedation with dexmedetomidine given through caudal or intravenous route(Monitoring baseline HR BP SPO2 preoperatively)