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Clinical Trials/NCT04212208
NCT04212208UnknownNot Applicable

Pain Assessment in the Perioperative Area During IV Cannulation Using a Combination of EMLA and Low-frequency USG Probe Versus a Combination of EMLA Cream and High-frequency Probe in Pediatric Cases- A Randomized Control Trial

All India Institute of Medical Sciences, Rishikesh2 sites in 1 country120 target enrollmentStarted: February 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
120
Locations
2
Primary Endpoint
To compare the intensity of pain among control versus interventional groups. Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)

Study Overview

Brief Summary

This study is mainly focusing on reducing the pain scores during IV cannulation in pediatric population in the preoperative period. Applying EMLA cream is a well-known fact world wide. we would like to study the effect of ultrasound waves in the penetration of the given drung into the skin so that we could achieve the effect of the drug quickly.

Detailed Description

To assess the intensity of pain in children in the perioperative area during IV cannulation using a combination of EMLA cream and low-frequency USG probe. To assess the intensity of pain in children in the perioperative area during IV cannulation using a combination of EMLA cream and high-frequency USG probe and final comparison between these groups will assess the effect of ultrasound in the penetration of the drug into the skin.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
5 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All children in the preoperative period.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To compare the intensity of pain among control versus interventional groups. Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)

Time Frame: 15minutes

to check the efficacy of high-frequency ultrasound probe in comparison to low-frequency probe in aiding the drug penetration there by decreasing the pain intensity during IV cannulation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

ADABALA VIJAY BABU

PRINCIPLE INVESTIGATOR

All India Institute of Medical Sciences, Rishikesh

Study Sites (2)

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