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| Name | Class |
|---|---|
| Mayday Fund | OTHER |
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A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Other | venipuncture with vapocoolant spray offered |
|
| Buzzy | Experimental | Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buzzy | Device | "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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 minute |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy L Baxter, MD | Children's Healthcare of Atlanta | Principal Investigator |
| Lindsey L Cohen, PhD | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta, Scottish Rite | Atlanta | Georgia | 30342 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22134226 | Derived | Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4. |
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Willing to share deidentified data with anyone interested in similar research.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | venipuncture with vapocoolant spray offered vapocoolant: venipuncture with vapocoolant spray offered |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | venipuncture with vapocoolant spray offered vapocoolant: venipuncture with vapocoolant spray offered |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | units on a scale | 5 minute |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | venipuncture with vapocoolant spray offered vapocoolant: venipuncture with vapocoolant spray offered |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Baxter | MMJ Labs | 877-805-2899 | 106 | abaxter@mmjlabs.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| vapocoolant | Other | venipuncture with vapocoolant spray offered |
|
|
| 5 minute |
| Number of Participants With Venipuncture Success in One Attempt | 5 minutes |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. | Posted | Median | Full Range | units on a scale | 5 minute |
|
|
|
| Secondary | Number of Participants With Venipuncture Success in One Attempt | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. | 0 | 41 | 0 | 41 |
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