Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

Pain Clinical Trial

Official title:

Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919100
• Other study ID #: CON007573
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: November 2018
• Source: Georgia State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• 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.

Other:
• vapocoolant
venipuncture with vapocoolant spray offered

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta, Scottish Rite	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia State University	Mayday Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faces Pain Scale-Revised (FPS-R)	Self-report measure of pain via 6 faces ranging from neutral to increasing pain expression. The scoring for the scale ranges from 0-10 with lower scores representing lower pain and higher scores representing higher pain. The FPS-R was conducted several minutes following venipuncture. This time was not tracked, but it was typically between 2-5 minutes following completion of the venipuncture.	5 minute
Secondary	OSBD-R Observational Pain/Distress Scale	The Observational Scale of Behavioral Distress (OSBD) is a validated and commonly used scale. There are 11 OSBD distress responses (information seeking, cry, scream, physical restraint, verbal resistance, seeking emotional support, verbal pain, flail, verbal fear, muscular rigidity, and nervous behavior). Using videotapes of the venipuncture, a composite OSBD score of 1 (low distress) to 11 (high distress) was assigned from the time of placement of tourniquet to placement of the bandage or securing the intravenous line (IV) after the first attempt. Two students not associated with the hospital or the device had been previously trained in this methodology and coded all tapes. A supervisor assessed interrater reliability on each coded behavior. After each group of 10 subjects, interrater agreements that fell below the level of excellent agreement (kappa = 0.80) were reviewed and discussed by both coders, with the consensus score recorded and definitions of observed behaviors.	5 minute
Secondary	Number of Participants With Venipuncture Success in One Attempt		5 minutes