Intravenous Administration
Conditions
Keywords
analgesic, anxiolytic, Buzzy Bee, Shot-blocker
Brief summary
The purpose of this study is to compare the anxiety and pain levels of patients when using Buzzy with ice, Vapocoolant, and placebo when inserting IV's line for IV fluids and/or phlebotomy in pediatric patients in the pediatric emergency department.
Interventions
DEVICEBuzzy 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.
DRUGVapocoolent
Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.
OTHERPlacebo
A band will be placed on the arm before IV insertion for placebo effect.
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Need IV's line placement for IV fluids and/or phlebotomy
Exclusion criteria
* patients sensitive to cold i.e. Raynaud's * critically ill patients * mentally challenged patients * GCS\< 15 * Patient with altered sensation * Patients needing more than one attempt at IV placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent | post intervention | 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 |
| Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver | post intervention | Faces Pain Scale revised with scores: scale is 0-10, with 0 being no pain and 10 maximum pain. |
Countries
United States
Participant flow
Recruitment details
221 Patients were approached by research assistants in the Emergency Department, 37 refused consent and 5 excluded due to medical reasons
Pre-assignment details
7 patients were then excluded due to multiple IV attempts
Participants by arm
| Arm | Count |
|---|---|
| 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. | 57 |
| 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. | 56 |
| 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. | 58 |
| Total | 171 |
Baseline characteristics
| Characteristic | Total | Buzzy Bee | Placebo | Vapocoolant |
|---|---|---|---|---|
| Age, Categorical <=18 years | 171 Participants | 56 Participants | 58 Participants | 57 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.6 years STANDARD_DEVIATION 3.9 | 12.6 years STANDARD_DEVIATION 3.8 | 12.7 years STANDARD_DEVIATION 4 | 12.4 years STANDARD_DEVIATION 4.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 11 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 131 Participants | 37 Participants | 49 Participants | 45 Participants |
| Region of Enrollment United States | 171 participants | 56 participants | 58 participants | 57 participants |
| Sex: Female, Male Female | 98 Participants | 27 Participants | 38 Participants | 33 Participants |
| Sex: Female, Male Male | 73 Participants | 29 Participants | 20 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 56 | 0 / 58 |
| other Total, other adverse events | 0 / 57 | 0 / 56 | 0 / 58 |
| serious Total, serious adverse events | 0 / 57 | 0 / 56 | 0 / 58 |
Outcome results
Primary
Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent
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
Time frame: post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Vapocoolant | 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 |
| Buzzy Bee | Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent | Pre-intervention | 5.41 units on a scale | Standard Deviation 2.9 |
| Buzzy Bee | Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent | Post-intervention | 3.58 units on a scale | Standard Deviation 2.87 |
| Placebo | Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent | Pre-intervention | 5.03 units on a scale | Standard Deviation 3.01 |
| Placebo | Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent | Post-intervention | 4.57 units on a scale | Standard Deviation 3.43 |
Primary
Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver
Faces Pain Scale revised with scores: scale is 0-10, with 0 being no pain and 10 maximum pain.
Time frame: post intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Vapocoolant | 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 |
| Buzzy Bee | Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver | Pre-intervention | 3.46 units on a scale | Standard Deviation 2.88 |
| Buzzy Bee | Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver | Post-intervention | 1.69 units on a scale | Standard Deviation 2.28 |
| Placebo | Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver | Pre-intervention | 2.86 units on a scale | Standard Deviation 2.85 |
| Placebo | Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver | Post-intervention | 2.79 units on a scale | Standard Deviation 2.84 |