Pain Assessment in the Perioperative Area
EMLA
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 18, 2019
CompletedFirst Posted
Study publicly available on registry
December 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedDecember 27, 2019
December 1, 2019
11 months
December 18, 2019
December 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Intervention group
EXPERIMENTALEMLA 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)
Control group
ACTIVE COMPARATOREMLA 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)
Interventions
Eligibility Criteria
You may qualify if:
- All children in the preoperative period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AIIMS
Rishikesh, Uttarakhand, 249203, India
Related 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.
PMID: 24583666BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Vijay Adabala, MD
AIIMS Rishikesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PRINCIPLE INVESTIGATOR
Study Record Dates
First Submitted
December 18, 2019
First Posted
December 26, 2019
Study Start
February 1, 2019
Primary Completion
December 26, 2019
Study Completion
January 1, 2020
Last Updated
December 27, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share