Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement

University at Buffalo (UB)

Status and phase: Completed; Phase 3

Conditions: Intravenous Administration

Treatments: Device: Buzzy Bee; Other: Placebo; Drug: Vapocoolent

Study type: Interventional

Funder types: Other

Identifiers

NCT06182631

STUDY00002993

Details and patient eligibility

About

The purpose of this study is to compare the anxiety and pain levels of patients when using Buzzy with ice, Vapocoolant, and placebo when inserting IV's line for IV fluids and/or phlebotomy in pediatric patients in the pediatric emergency department.

Enrollment: 172 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Need IV's line placement for IV fluids and/or phlebotomy

Exclusion criteria

• patients sensitive to cold i.e. Raynaud's
• critically ill patients
• mentally challenged patients
• GCS< 15
• Patient with altered sensation
• Patients needing more than one attempt at IV placement

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 3 patient groups, including a placebo group

Vapocoolant

Experimental group

Description:

Will have nurse spray vapocoolant on the skin before IV insertion, will then videotape patient and ask them and parent to fill out FACES form.

Treatment:

Drug: Vapocoolent

Buzzy Bee

Experimental group

Description:

Will have nurse put Buzzy Bee on arm before, and leave it on during IV insertion. Will then videotape patient and ask them and parent to fill out FACES form.

Treatment:

Device: Buzzy Bee

Placebo

Placebo Comparator group

Description:

Will have nurse place a rubber band around arm before IV insertion. Will then videotape patient and ask them and parent to fill out FACES form.

Treatment:

Other: Placebo