Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

NCT ID: NCT00919100

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-08-31

Brief Summary

A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.

Detailed Description

Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10% of adults. Current pain relief options include numbing creams, vapocoolant spray, or injected lidocaine. 17 million pediatric IV access procedures are done yearly with no pain intervention. An inexpensive, immediately acting form of needle pain control could reduce needle phobia in the long term if demonstrated to be effective for needle pain.

This study will evaluate pain self report and parent report using the Faces Pain Scale revised, and video-coded OSBD-R scores for patients undergoing emergency department venous access or cannulation procedures. Demographic information, pre-procedural anxiety, and success data from the attempts at placement will be included.

Conditions

Pain

Study Design

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

Study Groups

Standard Care

venipuncture with vapocoolant spray offered

Group Type: OTHER

vapocoolant

Intervention Type: OTHER

venipuncture with vapocoolant spray offered

Buzzy

Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards.

Group Type: EXPERIMENTAL

Buzzy

Intervention Type: DEVICE

"Buzzy" is a vibrating cold pack attached with Velcro strap or tourniquet 5-10cm proximal to the site of venipuncture. The vibration is activated and the device remains in place throughout the procedure. The distraction cards are offered to the parents to show the children, with questions on the back and pictures on the front.

Interventions

Buzzy

"Buzzy" is a vibrating cold pack attached with Velcro strap or tourniquet 5-10cm proximal to the site of venipuncture. The vibration is activated and the device remains in place throughout the procedure. The distraction cards are offered to the parents to show the children, with questions on the back and pictures on the front.

Intervention Type: DEVICE

vapocoolant

venipuncture with vapocoolant spray offered

Intervention Type: OTHER

Other Intervention Names

BuzzyR; PainEase

Eligibility Criteria

Inclusion Criteria

• Patients requiring venipuncture in a pediatric emergency department
• Informed consent
• Patient assent

Exclusion Criteria

• Patients with sickle cell or other sensitivity to cold
• Nerve damage in the area
• Abrasion or break in skin where device would be placed
• Critically ill

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayday Fund

OTHER

Sponsor Role: collaborator

Georgia State University

OTHER

Sponsor Role: lead

Responsible Party

Lindsey L Cohen, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy L Baxter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Healthcare of Atlanta

Lindsey L Cohen, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

Children's Healthcare of Atlanta, Scottish Rite

Atlanta, Georgia, United States

Countries

United States

References

Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4.

Reference Type: DERIVED

PMID: 22134226 (View on PubMed)

Other Identifiers

CON007573

Identifier Type: -

Identifier Source: org_study_id