Viewing Study NCT06326125



Ignite Creation Date: 2024-05-06 @ 8:16 PM
Last Modification Date: 2024-10-26 @ 3:24 PM
Study NCT ID: NCT06326125
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2024-03-28
First Post: 2024-02-16

Brief Title: Pharmacology and Non-pharmacology Approaches in Reducing Childrens Pain and Fear During Painful Procedures
Sponsor: Uppsala University
Organization: Uppsala University

Study Overview

Official Title: Randomized Controlled Trial Examining the Effectiveness of Pharmacology and Non-pharmacology Approaches in Reducing Childrens Pain and Fear During Painful Procedures
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture
Detailed Description: Children frequently undergo unexpected and procedure-related pain while in hospital settings leading to adverse emotional and psychological effects The exposure to painful procedures particularly venipuncture commonly occurs in emergency units upon admission during hospital stays or during follow-up visits The mere act of inserting needles stands out as one of the most distressing medical procedures for children resulting in frightening and upsetting experiences for both the children and their parents throughout the hospitalization period

In the realm of pain management interventions can generally be classified into pharmacological and non-pharmacological approaches Within pharmacological interventions local anesthetics play a key role in addressing needle-related pain These anesthetics can permeate the cuticle and epidermal layers of intact skin reaching the dermis where nerve endings are situated thereby alleviating pain Notably a eutectic mixture of local anesthetics EMLA emulsion composed of 25 mg lidocaine and 25 mg prilocaine per gram has been explored in pediatric settings for managing venipuncture pain due to its effectiveness and minimally invasive nature

On the non-pharmacological front various strategies have been investigated for needle procedures in children including distraction techniques cognitive and behavioral therapy hypnosis and memory alteration Among these interventions distraction stands out as a straightforward method that can be promptly applied and requires minimal prior training A systematic review has demonstrated the effectiveness of distraction in alleviating pain associated with needle-related procedures

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None