Pharmacological and Nonpharmacological Methods for Children in Venipuncture Pain

NCT ID: NCT06901271

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2019-06-28

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.

Conditions

Procedural Pain Relief; Fear Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control Group

The control group received the routine venipuncture procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

EMLA Cream

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Cold spray

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Buzzy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Cold spray

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aynur Aytekin Ozdemir

OTHER

Sponsor Role: lead

Responsible Party

Aynur Aytekin Ozdemir

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aynur Aytekin Ozdemir, Professor

Role: PRINCIPAL_INVESTIGATOR

İstanbul Medeniyet University

Locations

Istanbul Medeniyet University

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28285862 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38142386 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33485746 (View on PubMed)

Other Identifiers

2018-3/19

Identifier Type: -

Identifier Source: org_study_id