Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552351
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Needle-Free Jet Injection Versus Traditional Lidocaine Needle Infiltration for Local Anesthesia in Infant Lumbar Puncture
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infiltration of 1 lidocaine in infants undergoing lumbar punctures
Our aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional lidocaine needle infiltration with J-tip
Our aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional lidocaine needle infiltration with J-tip
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 including needle injections and the application of topical anesthetic creams have been effective in managing pain and enhancing the outcomes of LPs Recently the introduction of needle-free jet injection technology such as the J-Tip system offers a quicker and less invasive method for delivering local anesthesia
This research compares the effectiveness of the J-Tip with that of traditional 1 lidocaine infiltration for local anesthesia during LPs in infants
The investigators 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 infiltration of 1 lidocaine in infants undergoing lumbar punctures
The aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional 1 lidocaine needle infiltration with administration of 1 lidocaine the J-Tip
Secondary outcomes include the number of attempts to successfully perform the LP perceptions of pain management effectiveness by ED providers the need for additional lidocaine skin condition at the LP site and the overall success rate of the LP procedures
EXPERIMENTAL DESIGN
A single-center randomized controlled trial will compare the efficacy of J-Tip-injected lidocaine with conventional needle-injected lidocaine in providing anesthesia for infants undergoing lumbar punctures
PROPOSED PROCEDURE
Infants aged 0 to 3 months presenting to the Oklahoma Childrens Hospital Emergency Department between July 1 2024 through June 30 2025 who require an LP as part of their ED evaluation will be recruited
Randomization Strategy
Participants who consent will be randomly divided into two groups one receiving local anesthesia via the J-Tip syringe containing 1 lidocaine experimental group and the other through needle infiltration with the same concentration of lidocaine control group Randomization assignments will be provided in sealed envelopes and kept with the study team to be included in a study packet along with the consent forms to be reviewed at the time of enrollment
The ED provider performing the LP will independently evaluate pain levels using the Neonatal Infant Pain Scale NIPS immediately before the LP begins and at the time of needle insertion
A brief period of up to 5 minutes will follow the topical anesthesia application to allow infants to calm and reach a steady state accounting for any initial discomfort or startle response
After the LP attending providers will complete a questionnaire detailing the number of attempts any encountered difficulties additional lidocaine usage their assessment of pain control during the procedure any skin changes at the LP site and LP success defined as obtaining cerebrospinal fluid
Outcome Measures
Primary Outcome Pain levels as measured by NIPS scores immediately before the LP and at needle insertion
The NIPS Neonatal Infant Pain Scale is a scoring system used to assess pain in newborns and infants up to 1 year of age It is a behavioral scale that evaluates specific criteria to determine the level of pain the infant may be experiencing
NIPS Scoring System
Facial Expression 0-1 points 0 Relaxed facial expression
1 Grimace Cry 0-2 points 0 No cry
1 Whimper
2 Vigorous cry Breathing Patterns 0-1 points
0 Relaxed breathing
1 Change in breathing patterns eg irregular fast or slow breathing Arm Movements 0-1 points 0 Relaxed no movement or only gentle movements
1 Flexed or extended movements restless jerking Leg Movements 0-1 points 0 Relaxed no movement or only gentle movements
1 Flexed or extended movements restless jerking State of Arousal 0-1 points 0 Sleeping or calm
1 Fussy
Scoring Interpretation
0-2 points Mild or no pain 3-4 points Moderate pain 5-7 points Severe pain
Secondary Outcomes Include the number of LP attempts any difficulties encountered open-ended providers perception of pain control 1-5 scale additional lidocaine use post-procedure skin reactions classified as minormoderate or severe induration bleeding and LP success Additionally it will be determined if the LP was traumatic by reviewing patient charts defined as having a cerebrospinal fluid CSF red blood cell RBC count of 1000 cellsmm³
Provider Information Details about the providers performing the LP including their level of training APP fellow attending resident and prior experience with LPs categorized as 0-5 6-10 11-20 20 attempts will be documented
Data will be entered into REDCap and only authorized key study personnel will have access Identifiers will be removed and the de-identified information may be used for future research without additional informed consent from the participant
This research compares the effectiveness of the J-Tip with that of traditional 1 lidocaine infiltration for local anesthesia during LPs in infants
The investigators 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 infiltration of 1 lidocaine in infants undergoing lumbar punctures
The aim is to evaluate the efficacy and feasibility of different local anesthetic techniques in the ED setting by comparing traditional 1 lidocaine needle infiltration with administration of 1 lidocaine the J-Tip
Secondary outcomes include the number of attempts to successfully perform the LP perceptions of pain management effectiveness by ED providers the need for additional lidocaine skin condition at the LP site and the overall success rate of the LP procedures
EXPERIMENTAL DESIGN
A single-center randomized controlled trial will compare the efficacy of J-Tip-injected lidocaine with conventional needle-injected lidocaine in providing anesthesia for infants undergoing lumbar punctures
PROPOSED PROCEDURE
Infants aged 0 to 3 months presenting to the Oklahoma Childrens Hospital Emergency Department between July 1 2024 through June 30 2025 who require an LP as part of their ED evaluation will be recruited
Randomization Strategy
Participants who consent will be randomly divided into two groups one receiving local anesthesia via the J-Tip syringe containing 1 lidocaine experimental group and the other through needle infiltration with the same concentration of lidocaine control group Randomization assignments will be provided in sealed envelopes and kept with the study team to be included in a study packet along with the consent forms to be reviewed at the time of enrollment
The ED provider performing the LP will independently evaluate pain levels using the Neonatal Infant Pain Scale NIPS immediately before the LP begins and at the time of needle insertion
A brief period of up to 5 minutes will follow the topical anesthesia application to allow infants to calm and reach a steady state accounting for any initial discomfort or startle response
After the LP attending providers will complete a questionnaire detailing the number of attempts any encountered difficulties additional lidocaine usage their assessment of pain control during the procedure any skin changes at the LP site and LP success defined as obtaining cerebrospinal fluid
Outcome Measures
Primary Outcome Pain levels as measured by NIPS scores immediately before the LP and at needle insertion
The NIPS Neonatal Infant Pain Scale is a scoring system used to assess pain in newborns and infants up to 1 year of age It is a behavioral scale that evaluates specific criteria to determine the level of pain the infant may be experiencing
NIPS Scoring System
Facial Expression 0-1 points 0 Relaxed facial expression
1 Grimace Cry 0-2 points 0 No cry
1 Whimper
2 Vigorous cry Breathing Patterns 0-1 points
0 Relaxed breathing
1 Change in breathing patterns eg irregular fast or slow breathing Arm Movements 0-1 points 0 Relaxed no movement or only gentle movements
1 Flexed or extended movements restless jerking Leg Movements 0-1 points 0 Relaxed no movement or only gentle movements
1 Flexed or extended movements restless jerking State of Arousal 0-1 points 0 Sleeping or calm
1 Fussy
Scoring Interpretation
0-2 points Mild or no pain 3-4 points Moderate pain 5-7 points Severe pain
Secondary Outcomes Include the number of LP attempts any difficulties encountered open-ended providers perception of pain control 1-5 scale additional lidocaine use post-procedure skin reactions classified as minormoderate or severe induration bleeding and LP success Additionally it will be determined if the LP was traumatic by reviewing patient charts defined as having a cerebrospinal fluid CSF red blood cell RBC count of 1000 cellsmm³
Provider Information Details about the providers performing the LP including their level of training APP fellow attending resident and prior experience with LPs categorized as 0-5 6-10 11-20 20 attempts will be documented
Data will be entered into REDCap and only authorized key study personnel will have access Identifiers will be removed and the de-identified information may be used for future research without additional informed consent from the participant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None