Trial Outcomes & Findings for Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement (NCT NCT06182631)
NCT ID: NCT06182631
Last Updated: 2025-10-02
Results Overview
Wong- Baker Faces Pain Scale with scores: scale is 0-10, with 0 being no pain and 10 maximum pain. The changes in pain between the treatment groups were analyzed using chi square and one-way ANOVA for categorical and continuous variables respectively. Pre and post FACES pain scale-revised were reported as means and standard deviations
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
172 participants
Primary outcome timeframe
post intervention
Results posted on
2025-10-02
Participant Flow
221 Patients were approached by research assistants in the Emergency Department, 37 refused consent and 5 excluded due to medical reasons
7 patients were then excluded due to multiple IV attempts
Participant milestones
| Measure |
Vapocoolant
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.
Vapocoolent: Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.
|
Buzzy Bee
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.
Buzzy Bee: The Buzzy is a vibrating palm-sized device with removable ice wings developed by MMJ Labs Atlanta, GA. It uses Melzack and Wall's Gait Control theorywhich asserts that activation of non-nociceptive fibers can interfere with signals from pain fibers thereby inhibiting pain.
|
Placebo
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.
Placebo: A band will be placed on the arm before IV insertion for placebo effect.
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
56
|
58
|
|
Overall Study
COMPLETED
|
57
|
56
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement
Baseline characteristics by cohort
| Measure |
Vapocoolant
n=57 Participants
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.
Vapocoolent: Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.
|
Buzzy Bee
n=56 Participants
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.
Buzzy Bee: The Buzzy is a vibrating palm-sized device with removable ice wings developed by MMJ Labs Atlanta, GA. It uses Melzack and Wall's Gait Control theorywhich asserts that activation of non-nociceptive fibers can interfere with signals from pain fibers thereby inhibiting pain.
|
Placebo
n=58 Participants
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.
Placebo: A band will be placed on the arm before IV insertion for placebo effect.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.4 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
12.6 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
12.7 years
STANDARD_DEVIATION 4 • n=5 Participants
|
12.6 years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
56 participants
n=7 Participants
|
58 participants
n=5 Participants
|
171 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: post interventionWong- Baker Faces Pain Scale with scores: scale is 0-10, with 0 being no pain and 10 maximum pain. The changes in pain between the treatment groups were analyzed using chi square and one-way ANOVA for categorical and continuous variables respectively. Pre and post FACES pain scale-revised were reported as means and standard deviations
Outcome measures
| Measure |
Vapocoolant
n=57 Participants
use of vapocoolant for IV placement
|
Buzzy Bee
n=56 Participants
Use of Buzzy Bee for IV placement
|
Placebo
n=58 Participants
IV placement without use of buzzy bee or vapocoolant
|
|---|---|---|---|
|
Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent
Pre-intervention
|
4.54 units on a scale
Standard Deviation 2.65
|
5.41 units on a scale
Standard Deviation 2.9
|
5.03 units on a scale
Standard Deviation 3.01
|
|
Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent
Post-intervention
|
3.84 units on a scale
Standard Deviation 3.12
|
3.58 units on a scale
Standard Deviation 2.87
|
4.57 units on a scale
Standard Deviation 3.43
|
PRIMARY outcome
Timeframe: post interventionFaces Pain Scale revised with scores: scale is 0-10, with 0 being no pain and 10 maximum pain.
Outcome measures
| Measure |
Vapocoolant
n=57 Participants
use of vapocoolant for IV placement
|
Buzzy Bee
n=56 Participants
Use of Buzzy Bee for IV placement
|
Placebo
n=58 Participants
IV placement without use of buzzy bee or vapocoolant
|
|---|---|---|---|
|
Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver
Pre-intervention
|
3.06 units on a scale
Standard Deviation 2.98
|
3.46 units on a scale
Standard Deviation 2.88
|
2.86 units on a scale
Standard Deviation 2.85
|
|
Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver
Post-intervention
|
2.24 units on a scale
Standard Deviation 2.56
|
1.69 units on a scale
Standard Deviation 2.28
|
2.79 units on a scale
Standard Deviation 2.84
|
Adverse Events
Vapocoolant
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buzzy Bee
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place