NCT06326125

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: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-12-15
• Primary completion: 2024-04-10
• Completion: 2024-04-10
• First posted: 2024-03-22
• Last updated: 2024-03-28

Locations

1 site across 1 country: Iraq