- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04212208
Pain Assessment in the Perioperative Area (EMLA)
December 25, 2019 updated by: ADABALA VIJAY BABU, All India Institute of Medical Sciences, Rishikesh
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
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Uttarakhand
-
Rishikesh, Uttarakhand, India, 249203
- Recruiting
- AIIMS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All children in the preoperative period.
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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)
|
IV cannulation in the preoperative period
|
Active Comparator: Control group
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)
|
IV cannulation in the preoperative period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Vijay Adabala, MD, AIIMS Rishikesh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Anticipated)
December 26, 2019
Study Completion (Anticipated)
January 1, 2020
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
December 23, 2019
First Posted (Actual)
December 26, 2019
Study Record Updates
Last Update Posted (Actual)
December 27, 2019
Last Update Submitted That Met QC Criteria
December 25, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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