PainNCT00919100
Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief
A study testing Buzzy and vapocoolant in people with Pain, run by Georgia State University at 1 site in United States.
Trial summary
A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Pain
- What is being tested?
- Buzzy and vapocoolant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients requiring venipuncture in a pediatric emergency department
- Informed consent
- Patient assent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta, Scottish Rite
Atlanta, Georgia, 30342
About this study
Official title: Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief
A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.
Read the 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.
- Conditions
- Pain
- Being tested
- Buzzy, vapocoolant
- Keywords
- pediatric, venipuncture, pain, vibration, vapocoolant
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuzzyDevice
Also called BuzzyR
"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.
vapocoolantOther
Also called PainEase
venipuncture with vapocoolant spray offered
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Other | venipuncture with vapocoolant spray offered Receives: Other: vapocoolant |
| Buzzy | Experimental | Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards. Receives: Device: Buzzy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minute
Secondary outcomes (2)
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.
Measured: 5 minute
Number of Participants With Venipuncture Success in One Attempt
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayday Fund
- Responsible party
- Principal investigator, Lindsey L Cohen, PhD, Georgia State University
- Investigators
- Amy L Baxter, MD, Principal investigator, Children's Healthcare of AtlantaLindsey L Cohen, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919100
- Sponsor's protocol ID
- CON007573
- Status last verified
- Nov 2018
- First submitted
- 11 Jun 2009
- Last updated
- 21 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Willing to share deidentified data with anyone interested in similar research.
Publications
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.
PubMed 22134226
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief
- ClinicalTrials.gov ID
- NCT00919100
- Acronym / sponsor ID
- CON007573
- Conditions
- Pain
- Keywords
- pediatric, venipuncture, pain, vibration, vapocoolant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Mayday Fund
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Posted 18 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Other | Other: vapocoolantvenipuncture with vapocoolant spray offered |
| Buzzy | Experimental | Device: BuzzyVibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients requiring venipuncture in a pediatric emergency department
- Informed consent
- Patient assent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuzzyAlso: BuzzyR"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. | Device | Buzzy |
| vapocoolantAlso: PainEasevenipuncture with vapocoolant spray offered | Other | Standard Care |
Primary outcome
Faces Pain Scale-Revised (FPS-R)
Time frame: 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.
2 secondary outcomes
OSBD-R Observational Pain/Distress Scale
Time frame: 5 minute
Number of Participants With Venipuncture Success in One Attempt
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22134226Baxter 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.
- Individual participant dataSharing planned: Undecided. Willing to share deidentified data with anyone interested in similar research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy L Baxter, MD principal investigator
Children's Healthcare of Atlanta
Lindsey L Cohen, PhD principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy and vapocoolant in people with Pain, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faces Pain Scale-Revised (FPS-R) (time frame: 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00919100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.