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

Sponsor
Uppsala University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05957718
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
13.1
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: TKTX cream
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effectiveness of TKTX Cream on Pain and Fear in Children During Venipuncture: A Randomized Controlled Trial
Actual Study Start Date :
Aug 2, 2022
Actual Primary Completion Date :
Feb 3, 2023
Anticipated Study Completion Date :
Sep 4, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: TKTX Group

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

Drug: TKTX cream
TKTX cream was used in several studies on Tatto and laser
Other Names:
  • Placebo (Vasaline)

    		•
    Placebo Comparator: Control Group

    In this group, we will use a Vasalin as Placebo

    Drug: TKTX cream
    TKTX cream was used in several studies on Tatto and laser
    Other Names:
  • Placebo (Vasaline)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Wong-Baker Scale Pain [2-3 min. after procedure]

      Was used to measure Children's pain scale

    Secondary Outcome Measures

    1. Child Fear Scale [2-3 min. after procedure]

      Was used to measure Children's fear scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • School-age Children and

    • Required needle procedures

    Exclusion Criteria:

    • Neurodevelopmental problems

    • Chronic disease

    • Taken Analgesic

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sherzad Khudeida Suleman Dihok Iraq 42012

    Sponsors and Collaborators

    • Uppsala University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Uppsala University
    ClinicalTrials.gov Identifier:
    NCT05957718
    Other Study ID Numbers:
    • Sherzad
    First Posted:
    Jul 24, 2023
    Last Update Posted:
    Jul 24, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Hypesthesia

    Study Results

    No Results Posted as of Jul 24, 2023