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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06326125
Enrollment
160
Registered
2024-03-22
Start date
2023-12-15
Completion date
2024-04-10
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

pain, anxiety, painful procedures

Brief summary

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

Detailed 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.

Interventions

BEHAVIORALTICK-B

TICK-B as art-based distraction

DRUGTKTX-Cream

TKTX-Cream as local anesthesia cream

OTHERTICK-B and TKTX-C

TICK-B and TkTx-C as combined intervention approche (pharmacology and non-pharmacology)

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
severity of Painbaseline, during, and immediately post-procedure.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.

Secondary

MeasureTime frameDescription
Fearbaseline, during, and immediately post-procedure.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.

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026