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NCT04212208 Clinical Trial

Pain Assessment in the Perioperative Area

Pain, Procedural Clinical Trial

— EMLA  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04212208
Other study ID # 11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date January 1, 2020

Study information
Verified date December 2019
Source All India Institute of Medical Sciences, Rishikesh
Contact AJIT KUMAR, MD
Phone 9910789377
Email ajitdr.ajit@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date January 1, 2020
Est. primary completion date December 26, 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria:

- All children in the preoperative period.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• IV cannulation
IV cannulation in the preoperative period

Locations
Country Name City State
India AIIMS Rishikesh Uttarakhand

Sponsors (1)
Lead Sponsor Collaborator
All India Institute of Medical Sciences, Rishikesh

Country where clinical trial is conducted

India, 

References & Publications (1)

Lucas VS, Burk RS, Creehan S, Grap MJ. Utility of high-frequency ultrasound: moving beyond the surface to detect changes in skin integrity. Plast Surg Nurs. 2014 Jan-Mar;34(1):34-8. doi: 10.1097/PSN.0000000000000031. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To compare the intensity of pain among control versus interventional groups. Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R) 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 15minutes
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