Clinical trial NCT06901271: Pharmacological and Nonpharmacological Methods for Children in Venipuncture Pain
Official title: The Effect of EMLA Cream, Cold Spray, and Buzzy on Venipuncture Pain and Fear in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain Relief
Fear Pain
Keywords: Procedural pain
venipuncture
children
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 192
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Procedural pain score- Visual Analog Scale (VAS)
timeFrame: Through painful procedure completion, an average of 5 minutes
measure: Procedural pain score- Wong-Baker FACES Pain Rating Scale
timeFrame: Through painful procedure completion, an average of 5 minutes
Secondary outcomes:
measure: Procedural fear score- Children's Fear Scale (CFS)
timeFrame: Through painful procedure completion, an average of 5 minutes
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Medeniyet University
state: İ̇stanbul
Study officials:
affiliation: İstanbul Medeniyet University
name: Aynur Aytekin Ozdemir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.