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Pharmacological and Nonpharmacological Methods for Children in Venipuncture Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06901271
Enrollment
192
Registered
2025-03-28
Start date
2018-03-29
Completion date
2019-06-28
Last updated
2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Pain Relief, Fear Pain

Keywords

Procedural pain, venipuncture, children

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.

Interventions

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

DEVICEBuzzy

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.

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

Sponsors

Aynur Aytekin Ozdemir
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

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.

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Procedural pain score- Visual Analog Scale (VAS)Through painful procedure completion, an average of 5 minutesThe 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 ScaleThrough painful procedure completion, an average of 5 minutesThe 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

MeasureTime frameDescription
Procedural fear score- Children's Fear Scale (CFS)Through painful procedure completion, an average of 5 minutesThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026