Pain Assessment in the Perioperative Area (EMLA)
Primary Purpose
Pain, Procedural
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
IV cannulation
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Procedural
Eligibility Criteria
Inclusion Criteria:
- All children in the preoperative period.
Exclusion Criteria:
Sites / Locations
- AIIMSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
EMLA cream + High-frequency USG probe kept for 15minutes.After 15 minutes IV cannulation will be done and Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)
EMLA cream+Low frequency USG probe kept over the cream for 15 minutes. IV cannulation will be done and Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04212208
First Posted
December 18, 2019
Last Updated
December 25, 2019
Sponsor
All India Institute of Medical Sciences, Rishikesh
1. Study Identification
Unique Protocol Identification Number
NCT04212208
Brief Title
Pain Assessment in the Perioperative Area
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 26, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, Rishikesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
EMLA cream + High-frequency USG probe kept for 15minutes.After 15 minutes IV cannulation will be done and Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
EMLA cream+Low frequency USG probe kept over the cream for 15 minutes. IV cannulation will be done and Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)
Intervention Type
Device
Intervention Name(s)
IV cannulation
Intervention Description
IV cannulation in the preoperative period
Primary Outcome Measure Information:
Title
To compare the intensity of pain among control versus interventional groups. Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)
Description
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
Time Frame
15minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All children in the preoperative period.
Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AJIT KUMAR, MD
Phone
9910789377
Email
ajitdr.ajit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijay Adabala, MD
Organizational Affiliation
AIIMS Rishikesh
Official's Role
Study Chair
Facility Information:
Facility Name
AIIMS
City
Rishikesh
State/Province
Uttarakhand
ZIP/Postal Code
249203
Country
India
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24583666
Citation
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.
Results Reference
background
Learn more about this trial
Pain Assessment in the Perioperative Area
We'll reach out to this number within 24 hrs