Chronic PainNCT05555173
IVs With Buzzy in Chronic Pain Patients
A study testing Buzzy in people with Chronic Pain and Acute Pain, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
Trial summary
The investigators are conducting a study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Acute Pain
- What is being tested?
- Buzzy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving lidocaine infusions at the pain clinic.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
About this study
The investigators are conducting a study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions.
Read the detailed description
IV placement is necessary for lidocaine infusions. Unfortunately, some patients say that placing an IV is painful. The investigators are conducting this study to evaluate two techniques that could make the placement of the IV more comfortable. Currently, some medical providers administer the IV without any pain-relieving techniques. Some medical providers place a device called Buzzy® on a patient's arm prior to the IV placement. The Buzzy® device is the combination of an ice pack and a vibrator in the shape of a bumble bee. Literature shows that the Buzzy® device makes IV placement more comfortable for children, but there is minimal data in regard to whether it is helpful for adult patients. The investigators are conducting this study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions. The use of the Buzzy® device in adults is the investigational part of the study. This device has been FDA approved for use.
- Conditions
- Chronic Pain, Acute Pain
- Being tested
- Buzzy
- Medical subject headings
- Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuzzyDevice
Buzzy is a small vibrating bee with ice-pack wings.
| Study group | Role | What they receive |
|---|---|---|
| Buzzy | Experimental | Buzzy will be applied 5 to 10 cm proximal (toward the subject's head) to the dorsum of the hand site immediately prior and throughout the intravenous catheter insertion attempt. Receives: Device: Buzzy |
| No Buzzy | No intervention | Subjects will have a 20g intravenous catheter inserted either in the left or right dorsum side of the hand without the Buzzy device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on the Numeric Rating Scale
Patients are asked to report their subjective pain on the Numeric Rating Scale from 0 to 10, where 0 = No Pain and 10 = Worst Pain.
Measured: through study completion, an average of 2 months
Secondary outcomes (1)
Satisfaction on the Visual Analog Scale
Patients are asked to report their subjective satisfaction with the IV placement on the Visual Analog Scale, where labeled face images represent satisfaction from very poor satisfaction to excellent satisfaction.
Measured: through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Oct 2022
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Why it stopped: Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Gerges, MD, Principal investigator, Pain Medicine Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555173
- Sponsor's protocol ID
- 00838
- Status last verified
- Feb 2026
- First submitted
- 16 Sep 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVs With Buzzy in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT05555173
- Acronym / sponsor ID
- 00838
- Conditions
- Chronic Pain, Acute Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting a study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions.
Detailed description
IV placement is necessary for lidocaine infusions. Unfortunately, some patients say that placing an IV is painful. The investigators are conducting this study to evaluate two techniques that could make the placement of the IV more comfortable. Currently, some medical providers administer the IV without any pain-relieving techniques. Some medical providers place a device called Buzzy® on a patient's arm prior to the IV placement. The Buzzy® device is the combination of an ice pack and a vibrator in the shape of a bumble bee. Literature shows that the Buzzy® device makes IV placement more comfortable for children, but there is minimal data in regard to whether it is helpful for adult patients. The investigators are conducting this study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions. The use of the Buzzy® device in adults is the investigational part of the study. This device has been FDA approved for use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buzzy | Experimental | Device: BuzzyBuzzy will be applied 5 to 10 cm proximal (toward the subject's head) to the dorsum of the hand site immediately prior and throughout the intravenous catheter insertion attempt. |
| No Buzzy | No intervention | –Subjects will have a 20g intravenous catheter inserted either in the left or right dorsum side of the hand without the Buzzy device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving lidocaine infusions at the pain clinic.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| BuzzyBuzzy is a small vibrating bee with ice-pack wings. | Device | Buzzy |
Primary outcome
Pain on the Numeric Rating Scale
Time frame: through study completion, an average of 2 months
Patients are asked to report their subjective pain on the Numeric Rating Scale from 0 to 10, where 0 = No Pain and 10 = Worst Pain.
1 secondary outcome
Satisfaction on the Visual Analog Scale
Time frame: through study completion, an average of 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Frederic Gerges, MD principal investigator
Pain Medicine Physician
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 in people with Chronic Pain and Acute Pain, run by Steward St. Elizabeth's Medical Center of Boston, Inc. 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Feb 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain on the Numeric Rating Scale (time frame: through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2026.