Trial Outcomes & Findings for Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief (NCT NCT00919100)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

5 minute

Results posted on

2018-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Care venipuncture with vapocoolant spray offered vapocoolant: venipuncture with vapocoolant spray offered	Buzzy Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards. 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.
Overall Study STARTED	40	41
Overall Study COMPLETED	40	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=40 Participants venipuncture with vapocoolant spray offered vapocoolant: venipuncture with vapocoolant spray offered	Buzzy n=41 Participants Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards. 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.	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	40 Participants n=93 Participants	41 Participants n=4 Participants	81 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	9.91 years n=93 Participants	10.10 years n=4 Participants	10.0 years n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	16 Participants n=4 Participants	38 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	25 Participants n=4 Participants	43 Participants n=27 Participants
Region of Enrollment United States	40 Participants n=93 Participants	41 Participants n=4 Participants	81 Participants n=27 Participants

PRIMARY outcome

Timeframe: 5 minute

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.

Outcome measures

Outcome measures
Measure	Standard Care n=40 Participants venipuncture with vapocoolant spray offered vapocoolant: venipuncture with vapocoolant spray offered	Buzzy n=41 Participants Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards. 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.
Faces Pain Scale-Revised (FPS-R)	4 units on a scale Interval 2.0 to 6.0	2 units on a scale Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: 5 minute

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.

Outcome measures

Outcome measures
Measure	Standard Care n=40 Participants venipuncture with vapocoolant spray offered vapocoolant: venipuncture with vapocoolant spray offered	Buzzy n=41 Participants Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards. 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.
OSBD-R Observational Pain/Distress Scale	2 units on a scale Interval 1.0 to 3.0	1 units on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 5 minutes

Outcome measures

Outcome measures
Measure	Standard Care n=40 Participants venipuncture with vapocoolant spray offered vapocoolant: venipuncture with vapocoolant spray offered	Buzzy n=41 Participants Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards. 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.
Number of Participants With Venipuncture Success in One Attempt	26 Participants	35 Participants

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Buzzy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amy Baxter

MMJ Labs

Phone: 877-805-2899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place