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

NCT ID: NCT05957718

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2023-09-04

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.

Conditions

Pain; Fear of Pain; Venipuncture Site Numbness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

TKTX Group

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

Group Type: EXPERIMENTAL

TKTX cream

Intervention Type: DRUG

TKTX cream was used in several studies on Tatto and laser

Control Group

In this group, we will use a Vasalin as Placebo

Group Type: PLACEBO_COMPARATOR

TKTX cream

Intervention Type: DRUG

TKTX cream was used in several studies on Tatto and laser

Interventions

TKTX cream

TKTX cream was used in several studies on Tatto and laser

Intervention Type: DRUG

Other Intervention Names

Placebo (Vasaline)

Eligibility Criteria

Inclusion Criteria

• School-age Children and
• Required needle procedures

Exclusion Criteria

• Neurodevelopmental problems
• Chronic disease
• Taken Analgesic

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sherzad Khudeida Suleman

Dihok, , Iraq

Countries

Iraq

Other Identifiers

Sherzad

Identifier Type: -

Identifier Source: org_study_id