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Pain Assessment in the Perioperative Area

NCT ID: NCT04212208

Last Updated: 2019-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-01-01

Brief Summary

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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

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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.

Conditions

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Pain, Procedural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

IV cannulation

Intervention Type DEVICE

IV cannulation in the preoperative period

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)

Group Type ACTIVE_COMPARATOR

IV cannulation

Intervention Type DEVICE

IV cannulation in the preoperative period

Interventions

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IV cannulation

IV cannulation in the preoperative period

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All children in the preoperative period.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences, Rishikesh

OTHER_GOV

Sponsor Role lead

Responsible Party

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ADABALA VIJAY BABU

PRINCIPLE INVESTIGATOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vijay Adabala, MD

Role: STUDY_CHAIR

AIIMS Rishikesh

Locations

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AIIMS

Rishikesh, Uttarakhand, India

Site Status RECRUITING

Countries

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India

Central Contacts

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AJIT KUMAR, MD

Role: CONTACT

Phone: 9910789377

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 24583666 (View on PubMed)

Other Identifiers

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11

Identifier Type: -

Identifier Source: org_study_id