Status:
NOT_YET_RECRUITING
Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture
Lead Sponsor:
University of Oklahoma
Conditions:
Anesthesia
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
We hypothesize that the J-Tip needle-free jet-injection system offers comparable pain control and greater provider satisfaction due to its less invasive nature compared to traditional needle infiltrat...
Detailed Description
Lumbar punctures (LPs) play a key role in diagnosing meningitis in febrile infants. The use of local anesthesia is critical to the success of these procedures. Traditional anesthesia techniques, inclu...
Eligibility Criteria
Inclusion
- Infants requiring lumbar puncture for diagnostic or therapeutic purposes
- Age 0 to 3 months
- Parental/guardian consent obtained
- Exclusion Criteria:
- Infants with known allergy or hypersensitivity to lidocaine or components of the needle-free jet injection device
- Infants with significant skin infection or dermatitis at the site of injection
- Infants with coagulopathy or any bleeding disorder
- Infants with any other condition that, in the opinion of the investigator, would make participation in the study unsafe or not in the best interest of the infant
Exclusion
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06552351
Start Date
November 1 2024
End Date
August 1 2025
Last Update
October 10 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oklahoma Children's Hospital
Oklahoma City, Oklahoma, United States, 73104