Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures

Pain Clinical Trial

Official title:

Randomized Controlled Trial Examining the Effectiveness of Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06326125
• Other study ID #: SherzadSH
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: April 10, 2024

Study information

• Verified date: March 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture

Description:

Children frequently undergo unexpected and procedure-related pain while in hospital settings, leading to adverse emotional and psychological effects. The exposure to painful procedures, particularly venipuncture, commonly occurs in emergency units, upon admission, during hospital stays, or during follow-up visits. The mere act of inserting needles stands out as one of the most distressing medical procedures for children, resulting in frightening and upsetting experiences for both the children and their parents throughout the hospitalization period. In the realm of pain management, interventions can generally be classified into pharmacological and non-pharmacological approaches. Within pharmacological interventions, local anesthetics play a key role in addressing needle-related pain. These anesthetics can permeate the cuticle and epidermal layers of intact skin, reaching the dermis where nerve endings are situated, thereby alleviating pain. Notably, a eutectic mixture of local anesthetics (EMLA) emulsion, composed of 25 mg lidocaine and 25 mg prilocaine per gram, has been explored in pediatric settings for managing venipuncture pain due to its effectiveness and minimally invasive nature. On the non-pharmacological front, various strategies have been investigated for needle procedures in children, including distraction techniques, cognitive and behavioral therapy, hypnosis, and memory alteration. Among these interventions, distraction stands out as a straightforward method that can be promptly applied and requires minimal prior training. A systematic review has demonstrated the effectiveness of distraction in alleviating pain associated with needle-related procedures.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: April 10, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion:

School-aged 6-12 years old. Children who require PIVC.

Exclusion:

1. Chronic diseases,

2. Physical impairment,

3. Disability contributes to difficult communication,

4. Children of unsatisfied parents,

5. Children with neurodevelopment delays,

6. Cognitive impairment, hearing impairment, or visual impairment,

7. Taking an analgesic within 6 hours, or those with a syncope history.

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• TICK-B
TICK-B as art-based distraction

Drug:
• TKTX-Cream
TKTX-Cream as local anesthesia cream

Other:
• TICK-B and TKTX-C
TICK-B and TkTx-C as combined intervention approche (pharmacology and non-pharmacology)

Locations

Country	Name	City	State
Iraq	Sherzad Khudeida Suleman	Duhok	Erbil

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of Pain	Severity of pain will be assessed using Wong-Baker FACES Pain Rating Scale, a validated self-reporting tool widely utilized in clinical settings. Participants will be instructed to rate their pain on a scale from 0 (indicating no pain) to 10 (representing the worst imaginable pain). The Wong-Baker FACES Pain Rating Scale will be administered promptly after the completion of the procedure.	baseline, during, and immediately post-procedure.
Secondary	Fear	level of fear will be assessed using the Child Fear Scale (CFS), a validated instrument designed to measure the level of fear in pediatric populations. Participants will be asked to express their feelings of fear related to the procedure through the Child Fear Scale.	baseline, during, and immediately post-procedure.