Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT06552351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to receive either needle-free jet injection or traditional lidocaine needle infiltration for local anesthesia during infant lumbar puncture'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-08-12', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'Immediately post-procedure (within 5 minutes after the lumbar puncture)', 'description': 'The primary outcome measure will be the pain score of infants undergoing lumbar punctures, assessed using a validated pain scale appropriate for infants.'}, {'measure': 'Procedure Success Rate', 'timeFrame': 'During the procedure', 'description': 'The success rate of the lumbar puncture procedure, defined as obtaining an adequate CSF sample on the first attempt without the need for additional anesthesia.'}, {'measure': 'Caregiver Satisfaction', 'timeFrame': 'Within 1 hour post-procedure', 'description': 'Caregiver satisfaction with the anesthesia method used, measured using a standardized survey or questionnaire completed after the procedure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '15572969', 'type': 'BACKGROUND', 'citation': 'Baxter AL, Welch JC, Burke BL, Isaacman DJ. Pain, position, and stylet styles: infant lumbar puncture practices of pediatric emergency attending physicians. Pediatr Emerg Care. 2004 Dec;20(12):816-20. doi: 10.1097/01.pec.0000148030.99339.fe.'}, {'pmid': '29160002', 'type': 'BACKGROUND', 'citation': 'Caltagirone R, Raghavan VR, Adelgais K, Roosevelt GE. A Randomized Double Blind Trial of Needle-free Injected Lidocaine Versus Topical Anesthesia for Infant Lumbar Puncture. Acad Emerg Med. 2018 Mar;25(3):310-316. doi: 10.1111/acem.13351. Epub 2017 Dec 26.'}, {'type': 'BACKGROUND', 'citation': 'Use of Jet-Injected Lidocaine to Reduce Venipuncture Pain. AAP Grand Rounds, 2016. 35(2): p. 13-13.'}, {'pmid': '27055606', 'type': 'BACKGROUND', 'citation': 'Hajimaghsoudi M, Vahidi E, Momeni M, Arabinejhad A, Saeedi M. Comparison of local anesthetic effect of lidocaine by jet injection vs needle infiltration in lumbar puncture. Am J Emerg Med. 2016 Jul;34(7):1225-9. doi: 10.1016/j.ajem.2016.03.030. Epub 2016 Mar 16.'}, {'pmid': '17321005', 'type': 'BACKGROUND', 'citation': 'Nigrovic LE, Kuppermann N, Neuman MI. Risk factors for traumatic or unsuccessful lumbar punctures in children. Ann Emerg Med. 2007 Jun;49(6):762-71. doi: 10.1016/j.annemergmed.2006.10.018. Epub 2007 Feb 23.'}, {'pmid': '20404782', 'type': 'BACKGROUND', 'citation': 'Fein D, Avner JR, Khine H. Pattern of pain management during lumbar puncture in children. Pediatr Emerg Care. 2010 May;26(5):357-60. doi: 10.1097/PEC.0b013e3181db2026.'}, {'pmid': '22743744', 'type': 'BACKGROUND', 'citation': 'Ferayorni A, Yniguez R, Bryson M, Bulloch B. Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture: a randomized controlled trial. Pediatr Emerg Care. 2012 Jul;28(7):687-90. doi: 10.1097/PEC.0b013e31825d210b.'}, {'pmid': '21314772', 'type': 'BACKGROUND', 'citation': 'Hoyle JD Jr, Rogers AJ, Reischman DE, Powell EC, Borgialli DA, Mahajan PV, Trytko JA, Stanley RM. Pain intervention for infant lumbar puncture in the emergency department: physician practice and beliefs. Acad Emerg Med. 2011 Feb;18(2):140-4. doi: 10.1111/j.1553-2712.2010.00970.x.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nOur 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.', 'detailedDescription': "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.\n\nThis research compares the effectiveness of the J-Tip with that of traditional 1% lidocaine infiltration for local anesthesia during LPs in infants.\n\nThe 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.\n\nThe 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.\n\nSecondary 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.\n\nEXPERIMENTAL DESIGN:\n\nA 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.\n\nPROPOSED PROCEDURE:\n\nInfants aged 0 to 3 months presenting to the Oklahoma Children's Hospital Emergency Department between July 1, 2024, through June 30, 2025, who require an LP as part of their ED evaluation will be recruited.\n\nRandomization Strategy:\n\nParticipants 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.\n\nThe 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.\n\nA 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.\n\nAfter 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.\n\nOutcome Measures:\n\nPrimary Outcome: Pain levels, as measured by NIPS scores, immediately before the LP and at needle insertion.\n\nThe 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.\n\nNIPS Scoring System:\n\nFacial Expression (0-1 points) 0: Relaxed facial expression\n\n1: Grimace Cry (0-2 points) 0: No cry\n\n1. Whimper\n2. Vigorous cry Breathing Patterns (0-1 points)\n\n0: Relaxed breathing\n\n1: Change in breathing patterns (e.g., irregular, fast, or slow breathing) Arm Movements (0-1 points) 0: Relaxed, no movement or only gentle movements\n\n1: Flexed or extended movements (restless, jerking) Leg Movements (0-1 points) 0: Relaxed, no movement or only gentle movements\n\n1: Flexed or extended movements (restless, jerking) State of Arousal (0-1 points) 0: Sleeping or calm\n\n1: Fussy\n\nScoring Interpretation:\n\n0-2 points: Mild or no pain 3-4 points: Moderate pain 5-7 points: Severe pain\n\nSecondary Outcomes: Include the number of LP attempts, any difficulties encountered (open-ended), provider's perception of pain control (1-5 scale), additional lidocaine use, post-procedure skin reactions (classified as minor/moderate 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 cells/mm³.\n\nProvider 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.\n\nData 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Infants requiring lumbar puncture for diagnostic or therapeutic purposes\n\n* Age 0 to 3 months\n* Parental/guardian consent obtained\n\nExclusion Criteria:\n\n* Infants with known allergy or hypersensitivity to lidocaine or components of the needle-free jet injection device\n* Infants with significant skin infection or dermatitis at the site of injection\n* Infants with coagulopathy or any bleeding disorder\n* 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'}, 'identificationModule': {'nctId': 'NCT06552351', 'briefTitle': 'Needle-Free Lidocaine Injection vs Traditional Local Anesthesia in Infant Lumbar Puncture', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Needle-Free Jet Injection Versus Traditional Lidocaine Needle Infiltration for Local Anesthesia in Infant Lumbar Puncture', 'orgStudyIdInfo': {'id': '17204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Needle-Free Jet Injection of 1 % lidocaine', 'description': 'Device: Needle-Free Jet Injection The needle-free jet injection device delivers 1 % Lidocaine through high-pressure fluid without the use of a needle. This method aims to reduce the pain associated with needle-based anesthesia during infant lumbar punctures.\n\nOther Names:\n\n• Jet Injection Device, J-tip', 'interventionNames': ['Device: Needle-Free Jet Injection of 1 % lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Traditional needle infiltration of 1% lidocaine', 'description': 'Traditional needle infiltration involves injecting 1% lidocaine with a needle to provide local anesthesia before an infant lumbar puncture. This method is the standard practice for pain management in such procedures.\n\nOther Names:\n\n• traditional needle infiltration of 1% lidocaine', 'interventionNames': ['Other: traditional needle infiltration of 1% lidocaine']}], 'interventions': [{'name': 'Needle-Free Jet Injection of 1 % lidocaine', 'type': 'DEVICE', 'otherNames': ['Jet Injection Device, J-tip injection of 1 % lidocaine'], 'description': 'The needle-free jet injection device delivers 1% lidocaine through high-pressure fluid without the use of a needle. This method aims to reduce the pain associated with needle-based anesthesia during infant lumbar punctures.', 'armGroupLabels': ['Needle-Free Jet Injection of 1 % lidocaine']}, {'name': 'traditional needle infiltration of 1% lidocaine', 'type': 'OTHER', 'description': 'Traditional needle infiltration involves injecting 1% lidocaine with a needle to provide local anesthesia before an infant lumbar puncture. This method is the standard practice for pain management in such procedures.', 'armGroupLabels': ['Traditional needle infiltration of 1% lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'contacts': [{'name': 'Valorie Owens', 'role': 'CONTACT', 'email': 'valorie-owens@ouhsc.edu', 'phone': '405-271-2429', 'phoneExt': '44249'}, {'name': 'Olena Kostyuk, MD', 'role': 'CONTACT', 'email': 'olena-kostyuk@ouhsc.edu', 'phone': '6466434355'}], 'facility': "Oklahoma Children's Hospital", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'centralContacts': [{'name': 'Valorie Owens, MSW', 'role': 'CONTACT', 'email': 'Valorie-Owens@ouhsc.edu', 'phone': '405-271-2429', 'phoneExt': '44249'}, {'name': 'Olena Kostyuk, MD', 'role': 'CONTACT', 'email': 'Olena-Kostyuk@ouhsc.edu', 'phone': '646-643-4355'}], 'overallOfficials': [{'name': 'Jamie Laughy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are no plans to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}