The Use of Jet Injection Lidocaine for Blood Draws in Young Children
NCT ID: NCT01890642
Last Updated: 2015-10-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
205 participants
INTERVENTIONAL
2013-07-31
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion
NCT00924963
Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
NCT01224431
Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy
NCT02649322
Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture
NCT06552351
Jet Lidocaine for Pain Relief During Needle Insertion in a Pediatric Emergency Department
NCT00681902
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
J tip Noise
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
J tip
This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray
Cold Spray used to anesthetize the skin
Sucrose
Oral Sucrose used for children \< 1 year
Pain Ease
This group will receive Pain Ease Spray only if \> 1 yr or sucrose only if child \< 1 yr
Pain Ease Spray
Cold Spray used to anesthetize the skin
Sucrose
Oral Sucrose used for children \< 1 year
J tip
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
J tip
This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
1% buffered lidocaine
Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray)
Normal Saline Sprayed as placebo for Pain Ease spray
Sucrose
Oral Sucrose used for children \< 1 year
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
J tip
This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
Pain Ease Spray
Cold Spray used to anesthetize the skin
1% buffered lidocaine
Lidocaine placed using Jet Injection
placebo cooling spray (normal saline spray)
Normal Saline Sprayed as placebo for Pain Ease spray
Sucrose
Oral Sucrose used for children \< 1 year
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
6 Months
6 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical College of Wisconsin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maren Lunoe, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Amy Drendel, DO, MS
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
443133-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.