PainNCT01890642
The Use of Jet Injection Lidocaine for Blood Draws in Young Children
A study testing J tip, Pain Ease Spray and 1% buffered lidocaine in people with Pain, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in children ages 6 and younger. The investigators will use video observation of patients to asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain Ease spray 3) Pain Ease spray plus the J tip… Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- J tip, Pain Ease Spray and 1% buffered lidocaine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2013
- 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 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 months-6 years seen in the Children's Hospital of Wisconsin outpatient laboratory that have an order for venipuncture for a blood draw
Who cannot join
- Previous adverse reaction to lidocaine or Pain Ease spray
- Pre-existing skin lesion at site of blood draw
- Needle stick for IV insertion or lab draw that has already occurred at current hospital visit
- Patients who are physically unable to move their arms or legs
- Patients who are unable to cry
- Patients with connective tissue disorders that predispose to easy bruising
- Patients with bleeding disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Use Of The Needle Free Jet-Injection System With Buffered Lidocaine (J-Tip) For The Treatment Of Pain During Venipuncture For Blood Draws In Young Children
This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in children ages 6 and younger. The investigators will use video observation of patients to asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain Ease spray 3) Pain Ease spray plus the J tip noise.
Read the detailed description
No change since last report.
- Conditions
- Pain
- Being tested
- J tip, Pain Ease Spray, 1% buffered lidocaine, placebo cooling spray (normal saline spray), Sucrose
- Keywords
- Pain, Children, Venipuncture, J tip, Lidocaine, video observation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J tipDevice
This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease SprayOther
Also called Cooling Spray
Cold Spray used to anesthetize the skin
1% buffered lidocaineDrug
Also called Lidocaine
Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray)Other
Also called Normal Saline Spray
Normal Saline Sprayed as placebo for Pain Ease spray
SucroseOther
Also called Sweetease
Oral Sucrose used for children < 1 year
| Study group | Role | What they receive |
|---|---|---|
| J tip Noise | Sham comparator | This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray if > age 1 yr or sucrose if < 1 yr Receives: Device: J tip; Other: Pain Ease Spray; Other: Sucrose |
| Pain Ease | Other | This group will receive Pain Ease Spray only if > 1 yr or sucrose only if child < 1 yr Receives: Other: Pain Ease Spray; Other: Sucrose |
| J tip | Experimental | This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding if > 1 yr and will receive sucrose is < 1 yr Receives: Device: J tip; Drug: 1% buffered lidocaine; Other: placebo cooling spray (normal saline spray); Other: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture
Pain score assessed by video reviewer at J-tip, J-tip noise or researcher approach (1 minute) and at venipuncture (3 minutes). The score at J-tip noise/researcher approach was subtracted from the score at venipuncture to give a number indicating the change in pain scores.
The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.
Measured: 3 min
Secondary outcomes (4)
Pain Score
Pain score as assessed by video reviewers. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.
Measured: At venipuncture (3 minutes)
Fist Attempt Success
Proportion of patients where blood draw was successful on first attempt
Measured: up to 3 minutes
Change in Pain Score From Baseline
Pain score assessed by video reviewer before intervention (0 minute) and at venipuncture (3 minutes). The score at baseline was subtracted from the score at venipuncture to give a number indicating the change in pain scores.
The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.
Measured: 3 min
Pain at J-tip Deployment
Pain when J-tip deployed assessed by video reviewers using pain scale. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionAug 2013
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.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maren Lunoe, MD, Principal investigator, Medical College of WisconsinAmy Drendel, DO, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890642
- Sponsor's protocol ID
- 443133-1
- Status last verified
- Sep 2015
- First submitted
- 24 Jun 2013
- Last updated
- 6 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lunoe MM, Bolin AE, Drendel AL. An Evaluation of High Preprocedural Anxiety and Venipuncture Pain Experienced by Young Children. Pediatr Emerg Care. 2021 Oct 1;37(10):e621-e624. doi: 10.1097/PEC.0000000000002424.
PubMed 34591812
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of The Needle Free Jet-Injection System With Buffered Lidocaine (J-Tip) For The Treatment Of Pain During Venipuncture For Blood Draws In Young Children
- ClinicalTrials.gov ID
- NCT01890642
- Acronym / sponsor ID
- 443133-1
- Conditions
- Pain
- Keywords
- Pain, Children, Venipuncture, J tip, Lidocaine, video observation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Posted 6 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in children ages 6 and younger. The investigators will use video observation of patients to asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain Ease spray 3) Pain Ease spray plus the J tip noise.
Detailed description
No change since last report.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| J tip Noise | Sham comparator | Device: J tip, Other: Pain Ease Spray, Other: SucroseThis group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray if > age 1 yr or sucrose if < 1 yr |
| Pain Ease | Other | Other: Pain Ease Spray, Other: SucroseThis group will receive Pain Ease Spray only if > 1 yr or sucrose only if child < 1 yr |
| J tip | Experimental | Device: J tip, Drug: 1% buffered lidocaine, Other: placebo cooling spray (normal saline spray), Other: SucroseThis group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding if > 1 yr and will receive sucrose is < 1 yr |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6 months-6 years seen in the Children's Hospital of Wisconsin outpatient laboratory that have an order for venipuncture for a blood draw
Key exclusion criteria (7 listed)
- Previous adverse reaction to lidocaine or Pain Ease spray
- Pre-existing skin lesion at site of blood draw
- Needle stick for IV insertion or lab draw that has already occurred at current hospital visit
- Patients who are physically unable to move their arms or legs
- Patients who are unable to cry
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 |
|---|---|---|
| J tipThis is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine | Device | J tip, J tip Noise |
| Pain Ease SprayAlso: Cooling SprayCold Spray used to anesthetize the skin | Other | J tip Noise, Pain Ease |
| 1% buffered lidocaineAlso: LidocaineLidocaine placed using Jet Injection | Drug | J tip |
| placebo cooling spray (normal saline spray)Also: Normal Saline SprayNormal Saline Sprayed as placebo for Pain Ease spray | Other | J tip |
| SucroseAlso: SweeteaseOral Sucrose used for children < 1 year | Other | J tip, J tip Noise, Pain Ease |
Primary outcome
Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture
Time frame: 3 min
Pain score assessed by video reviewer at J-tip, J-tip noise or researcher approach (1 minute) and at venipuncture (3 minutes). The score at J-tip noise/researcher approach was subtracted from the score at venipuncture to give a number indicating the change in pain scores. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.
4 secondary outcomes
Pain Score
Time frame: At venipuncture (3 minutes)
Fist Attempt Success
Time frame: up to 3 minutes
Change in Pain Score From Baseline
Time frame: 3 min
Pain at J-tip Deployment
Time frame: 1 minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34591812Lunoe MM, Bolin AE, Drendel AL. An Evaluation of High Preprocedural Anxiety and Venipuncture Pain Experienced by Young Children. Pediatr Emerg Care. 2021 Oct 1;37(10):e621-e624. doi: 10.1097/PEC.0000000000002424.
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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.
Maren Lunoe, MD principal investigator
Medical College of Wisconsin
Amy Drendel, DO, MS principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing J tip, Pain Ease Spray and 1% buffered lidocaine in people with Pain, run by Medical College of Wisconsin 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 7 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 6 Oct 2015. 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. Some participants in this study may receive a placebo. 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 6 Oct 2015). 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?
Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture (time frame: 3 min). 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 NCT01890642, 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 6 Oct 2015.