Trial Outcomes & Findings for Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief (NCT NCT01394250)

Results Overview

The Faces Pain Scale Revised (FPS-R) is numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of "no pain" (0) to "very much pain" (10).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

240 participants

Primary outcome timeframe

Baseline and 30 minutes

Results posted on

2016-09-16

Participant Flow

Potential subjects were identified in the Emergency Department (ED) from 2011-2014. When ED nurse anticipated intravenous (IV) placement, a member of the study team was contacted to screen for study eligibility.

A total of 315 subjets signed informed consent forms. Of these 47 subjects were excluded prior to initiation of study procedures. Reasons included parent/child withdrawal of consent, change in clinical treatment plan including the decision to not place an IV for clinical reasons (study exclusion).

Participant milestones

Participant milestones
Measure	Buzzy® Buzzy® device was applied prior to intravenous cannulation.	Topical Lidocaine 4% Cream Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
Randomization and IV Placement Attempt STARTED	134	134
Randomization and IV Placement Attempt COMPLETED	120	121
Randomization and IV Placement Attempt NOT COMPLETED	14	13
Successful IV Placement & Follow-Up STARTED	120	121
Successful IV Placement & Follow-Up COMPLETED	114	110
Successful IV Placement & Follow-Up NOT COMPLETED	6	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Buzzy® Buzzy® device was applied prior to intravenous cannulation.	Topical Lidocaine 4% Cream Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
Randomization and IV Placement Attempt Unsuccessful IV Access on First Attempt	14	13
Successful IV Placement & Follow-Up Withdrawal by Subject	6	11

Baseline Characteristics

Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buzzy® n=114 Participants Buzzy® device was applied prior to intravenous cannulation.	Topical Lidocaine 4% Cream n=110 Participants Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.	Total n=224 Participants Total of all reporting groups
Age, Categorical <=18 years	114 Participants n=5 Participants	110 Participants n=7 Participants	224 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	52 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	58 Participants n=7 Participants	119 Participants n=5 Participants
Region of Enrollment United States	114 participants n=5 Participants	110 participants n=7 Participants	224 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 30 minutes

Population: Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.

The Faces Pain Scale Revised (FPS-R) is numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of "no pain" (0) to "very much pain" (10).

Outcome measures

Outcome measures
Measure	Buzzy® n=114 Participants Buzzy® device was applied prior to intravenous cannulation.	Topical Lidocaine 4% Cream n=110 Participants Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation	-3.544 units on a scale Interval -4.179 to -2.909	-3.436 units on a scale Interval -4.083 to -2.79

SECONDARY outcome

Timeframe: Up to 5 minutes after IV Cannulation

Population: Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.

The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The FLACC score was completed immediately after IV cannulation by a member of the clinical care team who was not part of the study. During initial trial design, the goal was to collect FLACC score pre and post cannulation; however, it was decided prior to enrollment that FLACC score would not be collected pre cannulation, only post.

Outcome measures

Outcome measures
Measure	Buzzy® n=114 Participants Buzzy® device was applied prior to intravenous cannulation.	Topical Lidocaine 4% Cream n=110 Participants Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
Comparison of the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Score Immediately After IV Cannulation Between Groups	0.667 units on a scale Interval 0.425 to 0.909	0.333 units on a scale Interval 0.084 to 0.582

Adverse Events

Buzzy®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical Lidocaine 4% Cream

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

Deb Potts

The Chidren's Hospital of Philadelphia

Phone: 215-590-7098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place