Effect of single shot intravenous dexmedetomidine for the supplementation of caudal analgesia in children - a prospective randomized comparative study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AIIMS
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To assess the effect of intravenous dexmedetomidine on caudal analgesia , to compare the time to rescue analgesia.
Study Overview
Brief Summary
Dexmedetomidine is a short acting selective alpha 2 agonist with sedative anxiolytic and analgesic properties. It has been used as adjunct to general and regional anaesthesia in adults.In adults, there are studies showing analgesic action of Intravenous dexmedetomidine on epidural block.
After a vast literature search ,we found that there are limited studies on the effect of intravenous dexmedetomidine on caudal analgesia in children. We hypothesis that intravenous dexmedetomidine might prolong the caudal analgesia in children. Hence we planned to conduct this study to evaluate the efficacy of intravenous dexmedetomidine for the supplementation of caudal analgesia in children.
the study results is statistically significant increase duration of analgesia with dexmedetomidine group of mean duration 425 minutes and that of saline group of 300 minutes
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA I-II Age 2- 8 yrs Undergoing urethroplasty.
Exclusion Criteria
- •Parental or guardian refusal Hypersensitivity to any local anaesthetic Bleeding diathesis Infection at puncture site Children with uncorrected heart disease Children with heart block or liver impairment Preexisting neurological diseases.
Outcomes
Primary Outcomes
To assess the effect of intravenous dexmedetomidine on caudal analgesia , to compare the time to rescue analgesia.
Time Frame: The duration of analgesia is from the time of caudal injection to the time of FLACC score 4.
Secondary Outcomes
- To compare the incidence of emergence agitation(To compare the time for discharge based on modified aldrete score.)