Pharmacological and Nonpharmacological Methods for Children in Venipuncture Pain

March 24, 2025 updated by: Aynur Aytekin Ozdemir

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İ̇stanbul
      • İstanbul, İ̇stanbul, Turkey, 34862
        • Istanbul Medeniyet University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group received the routine venipuncture procedure.
Experimental: Intervention 1 Group
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.
Drug: EMLA Cream
EMLA cream (2.5 grams) was applied to the treatment area 60 minutes before the procedure and covered with a transparent and impermeable dressing.
Experimental: Intervention 2 Group
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.
Drug: Cold spray
Cold spray was applied to the procedure area for 5 seconds from a distance of 15 cm immediately before the procedure.
Experimental: Intervention 3 Group
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.
Device: Buzzy
The buzzy device was placed on the procedure area 60 seconds before the procedure and turned on. The cold and vibration application continued during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through painful procedure completion, an average of 5 minutes
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.
Through painful procedure completion, an average of 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural fear score- Children's Fear Scale (CFS)
Time Frame: 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.
Through painful procedure completion, an average of 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aynur Aytekin Ozdemir

Investigators

  • Principal Investigator: Aynur Aytekin Ozdemir, Professor, Istanbul Medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2018

Primary Completion (Actual)

June 28, 2019

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-3/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

IPD Sharing Time Frame

July through December of 2026

IPD Sharing Access Criteria

Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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