Pain Assessment in the Perioperative Area

Not Applicable

• Conditions: Pain, Procedural
• Interventions: Device: IV cannulation

• Registration Number: NCT04212208
• Lead Sponsor: All India Institute of Medical Sciences, Rishikesh

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.

Study Timeline

• Study Start: 2019-02-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-23
• Last Update Submitted: 2019-12-25
• Primary Completion: 2019-12-26
• Study First Posted: 2019-12-26
• Last Update Posted: 2019-12-27
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• All children in the preoperative period.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	IV cannulation	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)
Control group	IV cannulation	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)

Primary Outcome Measures

Name	Time	Method
To compare the intensity of pain among control versus interventional groups. Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)	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

Trial Locations

Locations (1)

AIIMS; 🇮🇳 Rishikesh, Uttarakhand, India