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Completed

NCT Number: NCT06901271

Pharmacological and Nonpharmacological Methods for Children in Venipuncture Pain

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.

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Key information

Conditions

Procedural Pain Relief Fear Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University

Istanbul, 34862, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Cold spray

Drug

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aynur Aytekin Ozdemir

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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