Comparison of caudal clonidine versus caudal dexmedetomidine with bupivacaine for prolongation of postoperative analgesia in children undergoing infraumbilical surgeries.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1.TO COMPARE DURATION OF ANALGESIA IN BOTH GROUP.
Study Overview
Brief Summary
Bupivacaine is a long acting amide local anaesthetic. It is most frequently used for caudal anaesthesia in children that provides effective analgesia and motor blockade.Clonidine has been used for sedation, premedication and analgesia.Dexmedetomidine is a potent alpha 2 agonist (selective 2a subtype), widely used to provide analgesia, sedation and anxiolysis.Studies show increase in duration of post-operative analgesia on adding clonidine & dexmedetomidine to local anaesthetic. Both are a safe adjuvant to bupivacaine in pediatric caudal anaesthesia.We therefore decided to study the effects of combination of Bupivacaine and clonidine for prolongation of post-operative analgesia in children were evaluated and compared with the effect of combination of bupivacaine and Dexmedetomidine for prolongation of post-operative analgesia. Hemodynamic changes and side effects was also compared between both group, in children undergoing lower abdominal and perineal surgeries.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA I ,II AND III PATIENTS SCHEDULED FOR INFRA-UMBILICAL SURGERIES ELECTIVE SURGERIES.
- •CONSENT FROM LEGALLY AUTHORIZED REPRESENTATIVE.
Exclusion Criteria
- •ASA IV AND V PARENTS AND PATIENT RELATIVE REFUSING TO GIVE CONSENT PATIENTS HAVING PRE-EXISTING CARDIAC, NEUROLOGICAL AND RESPIRATORY DISEASES PATIENTS HAVING COAGULOPATHY PATIENTS WITH CONGENITAL SPINE ANOMALY LOCAL INFECTION/INFLAMMATION.
Outcomes
Primary Outcomes
1.TO COMPARE DURATION OF ANALGESIA IN BOTH GROUP.
Time Frame: 24 HR POST OPERATIVE ASSESSMENT OF PAIN RELIEF SCORE.
2.TO STUDY POSTOPERATIVE PAIN RELIEF IN BOTH GROUP.
Time Frame: 24 HR POST OPERATIVE ASSESSMENT OF PAIN RELIEF SCORE.
Secondary Outcomes
- 1.INTRAOPERATIVE HEMODYNAMIC PARAMETERS.(2.TO COMPARE INTRA OPERATIVE AND POSTOPERATIVE COMPLICATIONS RELATED TO DRUG AND COMPLICATION ASSOCIATED WITH TECHNIQUE.)
Investigators
NIRMALKUMAR MISTRY
B.J. MEDICAL COLLEGE AHMEDABAD