Pain
Conditions
Keywords
pediatric, venipuncture, pain, vibration, vapocoolant
Brief summary
A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.
Detailed 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.
Interventions
DEVICEBuzzy
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.
OTHERvapocoolant
venipuncture with vapocoolant spray offered
Sponsors
Mayday Fund
Georgia State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Faces Pain Scale-Revised (FPS-R) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OSBD-R Observational Pain/Distress Scale | 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. |
| Number of Participants With Venipuncture Success in One Attempt | 5 minutes | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care venipuncture with vapocoolant spray offered
vapocoolant: venipuncture with vapocoolant spray offered | 40 |
| 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. | 41 |
| Total | 81 |
Baseline characteristics
| Characteristic | Buzzy | Standard Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 41 Participants | 40 Participants | 81 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.10 years | 9.91 years | 10.0 years |
| Region of Enrollment United States | 41 Participants | 40 Participants | 81 Participants |
| Sex: Female, Male Female | 16 Participants | 22 Participants | 38 Participants |
| Sex: Female, Male Male | 25 Participants | 18 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 41 |
| serious Total, serious adverse events | 0 / 40 | 0 / 41 |
Outcome results
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.
Time frame: 5 minute
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Faces Pain Scale-Revised (FPS-R) | 4 units on a scale |
| Buzzy | Faces Pain Scale-Revised (FPS-R) | 2 units on a scale |
Secondary
Number of Participants With Venipuncture Success in One Attempt
Time frame: 5 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With Venipuncture Success in One Attempt | 26 Participants |
| Buzzy | Number of Participants With Venipuncture Success in One Attempt | 35 Participants |
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.
Time frame: 5 minute
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | OSBD-R Observational Pain/Distress Scale | 2 units on a scale |
| Buzzy | OSBD-R Observational Pain/Distress Scale | 1 units on a scale |