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Clinical Trials/NCT06901271
NCT06901271CompletedNot Applicable

The Effect of EMLA Cream, Cold Spray, and Buzzy on Venipuncture Pain and Fear in Children: a Randomized Controlled Trial

Aynur Aytekin Ozdemir1 site in 1 country192 target enrollmentStarted: March 29, 2018Last updated:
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
192
Locations
1
Primary Endpoint
Procedural pain score- Visual Analog Scale (VAS)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Investigator)

Eligibility Criteria

Ages
7 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Intervention 1 Group

Experimental

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: EMLA Cream (Drug)

Intervention 2 Group

Experimental

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: Cold spray (Drug)

Intervention 3 Group

Experimental

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.

Intervention: Buzzy (Device)

Outcomes

Primary Outcomes

Procedural pain score- Visual Analog Scale (VAS)

Time Frame: 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

Time Frame: 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 Outcomes

  • Procedural fear score- Children's Fear Scale (CFS)(Through painful procedure completion, an average of 5 minutes)

Investigators

Sponsor
Aynur Aytekin Ozdemir
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Aynur Aytekin Ozdemir

Professor

Istanbul Medeniyet University

Study Sites (1)

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