NCT05957718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

July 15, 2023

Last Update Submit

February 16, 2024

Conditions

PainFear of PainVenipuncture Site Numbness

Outcome Measures

Primary Outcomes (1)

  • Wong-Baker Scale Pain

    Was used to measure Children's pain scale

    2-3 min. after procedure

Secondary Outcomes (1)

  • Child Fear Scale

    2-3 min. after procedure

Study Arms (2)

TKTX Group

EXPERIMENTAL

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

Drug: TKTX cream

Control Group

PLACEBO COMPARATOR

In this group, we will use a Vasalin as Placebo

Drug: TKTX cream

Interventions

TKTX creamDRUG

TKTX cream was used in several studies on Tatto and laser

Also known as: Placebo (Vasaline)
Control GroupTKTX Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • School-age Children and
  • Required needle procedures

You may not qualify if:

  • Neurodevelopmental problems
  • Chronic disease
  • Taken Analgesic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherzad Khudeida Suleman

Duhok, 42012, Iraq

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2023

First Posted

July 24, 2023

Study Start

August 2, 2022

Primary Completion

February 3, 2023

Study Completion

September 4, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)