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Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial

Primary Purpose

Pain, Fear of Pain, Venipuncture Site Numbness

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
TKTX cream
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: School-age Children and Required needle procedures Exclusion Criteria: Neurodevelopmental problems Chronic disease Taken Analgesic

Sites / Locations

  • Sherzad Khudeida Suleman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TKTX Group

Control Group

Arm Description

In this group, We will use TKTX cream as a local anesthesia

In this group, we will use a Vasalin as Placebo

Outcomes

Primary Outcome Measures

Wong-Baker Scale Pain
Was used to measure Children's pain scale

Secondary Outcome Measures

Child Fear Scale
Was used to measure Children's fear scale

Full Information

First Posted
July 15, 2023
Last Updated
July 15, 2023
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT05957718
Brief Title
Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial
Official Title
Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
February 3, 2023 (Actual)
Study Completion Date
September 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Venipuncture, the process of obtaining blood samples for diagnostic purposes, is a common medical procedure performed worldwide. However, it can be associated with varying levels of pain and discomfort for patients. Therefore, implementing effective pain management strategies during venipuncture is crucial to ensure patient comfort and improve the overall healthcare experience. This comprehensive overview aims to highlight the significance of pain management during venipuncture procedures. This study will investigate the effects of a pharmacological approach on the pain that children experience during venipuncture in a randomized trial. TKTX topical anesthetic cream is a new commercially available product. In this study, the cream will be used for a shorter period of time than other creams used in previous studies, and it will also be free of side effects as they have been in previous studies with other creams.
Detailed Description
Venipuncture is a common medical procedure involving the insertion of a needle into a vein, often causing discomfort and pain. To alleviate this pain, pharmacological approaches have been widely explored. The efficacy of these approaches in managing venipuncture-related pain is of utmost importance for both healthcare professionals and patients. Various pharmacological options have been studied, including topical anesthetics such as lidocaine creams or patches, local anesthetic injections like buffered lidocaine or ethyl chloride spray, and systemic analgesics such as nonsteroidal anti-inflammatory drugs (NSAIDs) or opioids. You may experience some pain, often a brief sting, when the needle is inserted into and removed from your arm. Non-pharmacological pain intervention is a prophylactic and complementary approach to reduce pain. Ensuring safety and efficacy when performing blood draws on pediatric patients, while also accounting for their emotional and physical well-being is of utmost importance. Pharmacological intervention: Topical anesthetics To reduce the discomfort generated by a venipuncture, the use of a topical anaesthetic cream is recommended prior to needle procedures, with options including EMLA (r), amethocaine and lidocaine. Evaluating the effectiveness of these interventions requires considering factors like onset and duration of action, adequate pain relief achieved, patient satisfaction levels, and potential adverse effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fear of Pain, Venipuncture Site Numbness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TKTX Group
Arm Type
Experimental
Arm Description
In this group, We will use TKTX cream as a local anesthesia
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
In this group, we will use a Vasalin as Placebo
Intervention Type
Drug
Intervention Name(s)
TKTX cream
Other Intervention Name(s)
Placebo (Vasaline)
Intervention Description
TKTX cream was used in several studies on Tatto and laser
Primary Outcome Measure Information:
Title
Wong-Baker Scale Pain
Description
Was used to measure Children's pain scale
Time Frame
2-3 min. after procedure
Secondary Outcome Measure Information:
Title
Child Fear Scale
Description
Was used to measure Children's fear scale
Time Frame
2-3 min. after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: School-age Children and Required needle procedures Exclusion Criteria: Neurodevelopmental problems Chronic disease Taken Analgesic
Facility Information:
Facility Name
Sherzad Khudeida Suleman
City
Dihok
ZIP/Postal Code
42012
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial

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