Pharmacological and Nonpharmacological Methods for Children in Venipuncture Pain

Not Applicable

Completed

• Conditions: Procedural Pain Relief; Fear Pain
• Interventions: Drug: EMLA Cream; Drug: Cold spray; Device: Buzzy

• Registration Number: NCT06901271
• Lead Sponsor: Aynur Aytekin Ozdemir

Brief Summary

This study aimed to examine the effect of EMLA cream, cold spray, and Buzzy applied during venipuncture on the pain and fear levels of children aged 7-12 years.

Detailed Description

The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years. For pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects. Studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children. However, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable pharmacological and nonpharmacological methods can be used especially in acute settings. EMLA cream, cold spray, and Buzzy examined in this study may serve as alternative effective pharmacological and non-pharmacological methods to reduce venipuncture pain and fear.

Study Timeline

• Study Start: 2018-03-29
• Primary Completion: 2019-06-28
• Study Completion: 2019-06-28
• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• being between the ages of 7 to 12 years,
• literate,
• requiring blood tests

Exclusion Criteria

• having chronic diseases,
• hospital stay for treatment,
• visual, audio, or speech impairments,
• a history of allergies,
• mental disorders,
• history of sedative, analgesic, or narcotic use within 24 h before admission,
• inflammatory disease during admission.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention 1 Group	EMLA Cream	In this group, EMLA cream was applied to the procedure area (antecubital region) 60 minutes before the venipuncture procedure. Then, the venipuncture procedure was performed.
Intervention 2 Group	Cold spray	In this group, cold spray was applied to the procedure area for 5 seconds just before the venipuncture procedure. Then, the venipuncture procedure was performed.
Intervention 3 Group	Buzzy	In this group, Buzzy was placed in the procedure area. Buzzy was operated for 60 seconds. Then, the venipuncture procedure was performed. It also operated during this procedure.

Primary Outcome Measures

Name	Time	Method
Procedural pain score- Visual Analog Scale (VAS)	Through painful procedure completion, an average of 5 minutes	The VAS is used to measure and monitor pain intensity. VAS is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The participant is asked to mark a point on the line that best represents their pain level. The VAS score is determined by measuring the distance of the mark from the left end of the line. VAS is an easy-to-understand and easy-to-measure scale for children aged 7 and over
Procedural pain score- Wong-Baker FACES Pain Rating Scale	Through painful procedure completion, an average of 5 minutes	The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right. The first face is a happy face representing "no pain=0" while the last face is a crying face representing "the worst pain imaginable=5". Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain.

Secondary Outcome Measures

Name	Time	Method
Procedural fear score- Children's Fear Scale (CFS)	Through painful procedure completion, an average of 5 minutes	The CFS was developed to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral to extreme fear. It is scored between 0 and 4. Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures.

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 İstanbul, İ̇stanbul, Turkey