Propofol Injection Pain in ChildrenNCT07770581
Determining if the Buzzy® Personal Pain Relief Device Reduces Injection Pain of Propofol as Much as Intravenous Lidocaine in Children
A study testing Buzzy device and Intravenous lidocaine in people with Propofol Injection Pain in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
Propofol is a drug commonly used for induction of general anesthesia in children as well as adults; however, propofol can cause pain on injection, possibly more frequently in children. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Propofol Injection Pain in Children
- What is being tested?
- Buzzy device and Intravenous lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 30 Jun 2017
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who are in the American Society of Anesthesiologists with physical status classification I to III (meaning healthy patients, patients with mild systemic disease, and patients with serious controlled systemic disease)
- Between the ages of 12 and 17
- Presenting from home for procedures including, but not limited to, upper and lower endoscopy, orthopedic surgery, and medical imaging.
Who cannot join
- Patients requiring a rapid sequence induction of anesthesia and patients requiring an emergency procedure
- Patients requiring mask induction for anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: A Randomized Comparison of the Buzzy® Personal Pain Relief Device to Intravenous Lidocaine for Controlling Injection Pain During Intravenous Propofol Induction of Anesthesia in Children
Propofol is a drug commonly used for induction of general anesthesia in children as well as adults; however, propofol can cause pain on injection, possibly more frequently in children. One common method of preventing propofol injection pain is the injection of lidocaine just prior to the injection of propofol through an intravenous catheter. This practice is sometimes, but not universally, effective, and involves exposure of patients to an additional drug. Our proposal is to use a non-pharmacologic adjunct in an attempt to attenuate the pain of propofol injection. The Buzzy® personal pain relief device is an FDA-approved product that provides non-pharmacologic relief of pain from minor painful procedures in children. The investigators propose the non-invasive Buzzy® personal pain relief device might prove just as effective at relieving the pain of propofol injection as the injection of intravenous lidocaine just prior to propofol injection. Randomized groups and a blinded observer will be used in this study of 106 children, with one group of patients receiving a current standard of care for reduction of the pain of propofol injection, that is, lidocaine prior to propofol, and one group receiving the placement of the Buzzy® device above the injection site prior to injection of propofol to reduce the pain of propofol injection.
- Conditions
- Propofol Injection Pain in Children
- Being tested
- Buzzy device, Intravenous lidocaine
- Keywords
- propofol, Buzzy device, propofol injection pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy deviceDevice
Also called Buzzy personal pain relief device
Intravenous lidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Buzzy device | Experimental | Use of the Buzzy device during propofol induction in an attempt to alleviate propofol injection pain Receives: Device: Buzzy device |
| Intravenous lidocaine | Active comparator | Use of intravenous lidocaine during propofol induction in an attempt to alleviate propofol injection pain Receives: Drug: Intravenous lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of Buzzy pain relief device as compared to intravenous lidocaine at preventing pain on injection of propofol
Two scales will be used by the observer to rate the amount of pain, if any, on propofol injection, the FLACC (face, legs, activity, cry, consolability) Scale and the Cameron Four Point Scale for Pain on Propofol Injection. The FLACC Scale is a 0-10 scale where the observer rates pain based on facial expression, movement of the body and legs, vocalization, and reassurability. The Cameron Scale was developed by researchers to specifically rate the pain of propofol injection for a previous study, and uses the presence or absence of grimace, cry, and withdrawal to rate pain on a 0-3 scale. Both scales are being used because the FLACC Scale was not specifically designed for propofol pain, and has some limitations in its application for this purpose; however, the Cameron Scale is limited by its narrow application of three types of expressions of pain.
Measured: Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes
Secondary outcomes (1)
Vital Signs
The heart rate and blood pressure will be recorded just prior to induction of anesthesia, when 25% of the induction dose of propofol has been given, and every minute after induction of anesthesia for eight minutes. Heart rate and blood pressure variations will serve as a secondary indicator of pain on propofol injection.
Measured: Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startJun 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Why it stopped: PI left institution and study activity was not continued (enrollment not complete)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Injection Pain in ChildrenStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770581
- Sponsor's protocol ID
- Buzzy for propofol pain relief
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2014
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of the Buzzy® Personal Pain Relief Device to Intravenous Lidocaine for Controlling Injection Pain During Intravenous Propofol Induction of Anesthesia in Children
- ClinicalTrials.gov ID
- NCT07770581
- Acronym / sponsor ID
- Buzzy for propofol pain relief
- Conditions
- Propofol Injection Pain in Children
- Keywords
- propofol, Buzzy device, propofol injection pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution and study activity was not continued (enrollment not complete)
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Aug 2026 (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.
Propofol is a drug commonly used for induction of general anesthesia in children as well as adults; however, propofol can cause pain on injection, possibly more frequently in children. One common method of preventing propofol injection pain is the injection of lidocaine just prior to the injection of propofol through an intravenous catheter. This practice is sometimes, but not universally, effective, and involves exposure of patients to an additional drug. Our proposal is to use a non-pharmacologic adjunct in an attempt to attenuate the pain of propofol injection. The Buzzy® personal pain relief device is an FDA-approved product that provides non-pharmacologic relief of pain from minor painful procedures in children. The investigators propose the non-invasive Buzzy® personal pain relief device might prove just as effective at relieving the pain of propofol injection as the injection of intravenous lidocaine just prior to propofol injection. Randomized groups and a blinded observer will be used in this study of 106 children, with one group of patients receiving a current standard of care for reduction of the pain of propofol injection, that is, lidocaine prior to propofol, and one group receiving the placement of the Buzzy® device above the injection site prior to injection of propofol to reduce the pain of propofol injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buzzy device | Experimental | Device: Buzzy deviceUse of the Buzzy device during propofol induction in an attempt to alleviate propofol injection pain |
| Intravenous lidocaine | Active comparator | Drug: Intravenous lidocaineUse of intravenous lidocaine during propofol induction in an attempt to alleviate propofol injection pain |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who are in the American Society of Anesthesiologists with physical status classification I to III (meaning healthy patients, patients with mild systemic disease, and patients with serious controlled systemic disease)
- Between the ages of 12 and 17
- Presenting from home for procedures including, but not limited to, upper and lower endoscopy, orthopedic surgery, and medical imaging.
Key exclusion criteria (2 listed)
- Patients requiring a rapid sequence induction of anesthesia and patients requiring an emergency procedure
- Patients requiring mask induction for anesthesia
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 |
|---|---|---|
| Buzzy deviceAlso: Buzzy personal pain relief device | Device | Buzzy device |
| Intravenous lidocaine | Drug | Intravenous lidocaine |
Primary outcome
Non-inferiority of Buzzy pain relief device as compared to intravenous lidocaine at preventing pain on injection of propofol
Time frame: Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes
Two scales will be used by the observer to rate the amount of pain, if any, on propofol injection, the FLACC (face, legs, activity, cry, consolability) Scale and the Cameron Four Point Scale for Pain on Propofol Injection. The FLACC Scale is a 0-10 scale where the observer rates pain based on facial expression, movement of the body and legs, vocalization, and reassurability. The Cameron Scale was developed by researchers to specifically rate the pain of propofol injection for a previous study, and uses the presence or absence of grimace, cry, and withdrawal to rate pain on a 0-3 scale. Both scales are being used because the FLACC Scale was not specifically designed for propofol pain, and has some limitations in its application for this purpose; however, the Cameron Scale is limited by its narrow application of three types of expressions of pain.
1 secondary outcome
Vital Signs
Time frame: Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes
Results and safety
The study was stopped early (reason given: PI left institution and study activity was not continued (enrollment not complete)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 device and Intravenous lidocaine in people with Propofol Injection Pain in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 2 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: stopped early, as of the sponsor's last update on 18 Sep 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 stopped early (reason given: PI left institution and study activity was not continued (enrollment not complete)). Results are not available in the source record.
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?
Non-inferiority of Buzzy pain relief device as compared to intravenous lidocaine at preventing pain on injection of propofol (time frame: Every minute starting 1 minute prior to induction of anesthesia, during induction, and after induction of anesthesia for a total of ten minutes). 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 18 Sep 2026.