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

Uppsala University

Status: Invitation-only

Conditions: Pain

Treatments: Behavioral: TICK-B; Drug: TKTX-Cream; Other: TICK-B and TKTX-C

Study type: Interventional

Funder types: Other

Identifiers

NCT06326125

SherzadSH

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 4 patient groups

TICK-B

Experimental group

Description:

active distraction technique as non-pharmacology in treating children's pain and fear during venipuncture procedure.

Treatment:

Behavioral: TICK-B

TkTx-Cream

Experimental group

Description:

as Pharmacological approach will be use in managing children's pain and fear during venipuncture procedure.

Treatment:

Drug: TKTX-Cream

TICK-B and TkTx-C

Experimental group

Description:

Pharmacological approache and non-Pharmacological will be use in managing children's pain and fear during venipuncture procedure.

Treatment:

Other: TICK-B and TKTX-C

Control Group

No Intervention group

Description:

No intervention will applied in this group