Pharmacological and Nonpharmacological Methods for Children in Venipuncture Pain

NCT06901271 | Completed

• 1 other identifier: 2018-3/19
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain Relief; Fear Pain

Keywords

Procedural pain; venipuncture; children

Outcome Measures

Primary Outcomes (2)

• Procedural pain score- Visual Analog Scale (VAS)

  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

  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 Outcomes (1)

• Procedural fear score- Children's Fear Scale (CFS)

  Through painful procedure completion, an average of 5 minutes

Study Arms (4)

Control Group

NO INTERVENTION

The control group received the routine venipuncture procedure.

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.

Drug: EMLA Cream

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.

Drug: Cold spray

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.

Device: Buzzy

Interventions

EMLA Cream DRUG

EMLA cream (2.5 grams) was applied to the treatment area 60 minutes before the procedure and covered with a transparent and impermeable dressing.

Intervention 1 Group

Buzzy DEVICE

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.

Intervention 3 Group

Cold spray DRUG

Cold spray was applied to the procedure area for 5 seconds from a distance of 15 cm immediately before the procedure.

Intervention 2 Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aynur Aytekin Ozdemir: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Istanbul, 34862, Turkey (Türkiye)

Location

Related Publications (3)

• Dalvandi A, Ranjbar H, Hatamizadeh M, Rahgoi A, Bernstein C. Comparing the effectiveness of vapocoolant spray and lidocaine/procaine cream in reducing pain of intravenous cannulation: A randomized clinical trial. Am J Emerg Med. 2017 Aug;35(8):1064-1068. doi: 10.1016/j.ajem.2017.02.039. Epub 2017 Feb 27.

  PMID: 28285862 BACKGROUND

• Celik EG, Sonmez Duzkaya D. The Impact of Cold Spray and Ice Application During Intravenous Access on Pain and Fear in Children Aged 7-15 Years in the Pediatric Emergency Unit: A Randomized Controlled Trial. J Emerg Nurs. 2024 Mar;50(2):264-272. doi: 10.1016/j.jen.2023.11.012. Epub 2023 Dec 24.

  PMID: 38142386 BACKGROUND

• Erdogan B, Aytekin Ozdemir A. The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy(R) (Randomized Controlled Trial). J Pediatr Nurs. 2021 May-Jun;58:e54-e62. doi: 10.1016/j.pedn.2021.01.001. Epub 2021 Jan 21.

  PMID: 33485746 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Aynur Aytekin Ozdemir, Professor

  İstanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study was conducted as a randomized controlled trial in parallel groups. The variables used for blocking were age (7-9 and 10-12 years), sex (female and male), and fear of the procedure (yes and no). The blocks were repeated six times in each group (2 × 2 × 2 × 6 ), resulting in 48 participants per group.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 28, 2025
• Study Start: March 29, 2018
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: July through December of 2026
• 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.

Locations

TU (1)