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OpenTrials
Completed

NCT Number: NCT05957718

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sherzad Khudeida Suleman

Duhok, 42012, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • School-age Children and
  • Required needle procedures

Exclusion criteria

  • Neurodevelopmental problems
  • Chronic disease
  • Taken Analgesic

Treatment and study plan

TKTX cream

Drug

TKTX cream was used in several studies on Tatto and laser

Other names: Placebo (Vasaline)

Primary outcomes

  1. Wong-Baker Scale Pain

    Time frame: 2-3 min. after procedure

    Was used to measure Children's pain scale

Secondary outcomes

  1. Child Fear Scale

    Time frame: 2-3 min. after procedure

    Was used to measure Children's fear scale

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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