Clinical trial NCT06326125: Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures
Official title: Randomized Controlled Trial Examining the Effectiveness of Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pain
Keywords: pain, anxiety, painful procedures
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: severity of Pain
timeFrame: baseline, during, and immediately post-procedure.
Secondary outcomes:
measure: Fear
timeFrame: baseline, during, and immediately post-procedure.
Other outcomes:
Locations:
city: Duhok
country: Iraq
facility: Sherzad Khudeida Suleman
state: Erbil
Study officials:
affiliation: Uppsala University
name: Sherzad Suleman, MsC
role: PRINCIPAL_INVESTIGATOR
References: