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Clinical Trials/CTRI/2021/03/032151
CTRI/2021/03/032151CompletedNot Applicable

A Comparative study of dexmedetomidine versus dexamethasone as an adjuvant to 0.2% levobupivacaine in caudal block for post operative analgesia in paediatric patients undergoing infraumbilical surgeries

Jawaharlal Nehru medical college ajmer1 site in 1 country80 target enrollmentStarted: March 20, 2021Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Primary outcome of study will be assesment of Duration of analgesia (from the time of caudal injection to the time at which FLACC pain Pain score 4 or more)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of study will be  to compare the efficacy and safety of addition of dexmedetomidine versus dexamethasone to caudal 0.2% levobupivacaine on postoperative analgesia in paediatric patients undergoing infraumbilical surgeries

Primary objective  will be to assess duration of analgesia (from the time of caudal block to the time at which FLACC Pain score 4 or more)

Secondary objective will be to assess

1.postoperative sedation

  1. Hemodynamic changes

3.Total number of doses of rescue analgesia in 24 hours

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
1.00 Year(s) to 8.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.patients between the age group of 1year and 8year of both sexes undergoing various infraumbilical surgeries
  • •Patients belonging to ASA 1 and 2 grades 3.parental consent.

Exclusion Criteria

  • •1.patients with known allergy to the study drugs
  • •Suspected coagulopathy
  • •Infection at site of caudal block 4.History of developmental delay and neurological diseases
  • •Skeletal deformities in the caudal region 6.parental refusal.

Outcomes

Primary Outcomes

Primary outcome of study will be assesment of Duration of analgesia (from the time of caudal injection to the time at which FLACC pain Pain score 4 or more)

Time Frame: Duration of study will be around 1year

Secondary Outcomes

  • Secondary outcome of study will be assesment of 1.postoperative sedation(2. Hemodynamic changes)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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