Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain

The purpose of this study is to compare two medications used to numb an infant's back when performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain cerebrospinal fluid (CSF). This is achieved by inserting a small needle between the infant's vertebrae. In the past, doctors did not know if newborns could feel the pain from a procedure like this in the same way that adults do. Investigators now know that the newborns do experience pain during this procedure, but we do not know the best way to control this pain. Investigators also think that when the newborns have pain, they move during the test. The movement can increase the chance of having blood mix with this normally clear fluid leading to limitations in our clinical application of these results. This study will compare the injected and topical forms of Lidocaine to see which gives us better pain control and more clear results. The investigators hypothesize that subcutaneous 1% Lidocaine, due to its deeper penetration, will be 25% superior to topical liposomal Lidocaine (LMX-4) in both the rate of clinically useful results and pain scores. The investigators hypothesize that both forms of Lidocaine will be 25% superior to our historical control cohort in the rate of clinically useful results.

Study Overview

• Status: Terminated
• Conditions: Meningitis
• Intervention / Treatment: Drug: 1% lidocaine; Drug: topical lidocaine

Detailed Description

When the decision is made that an infant needs a lumbar puncture for clinical indications, parental consent will be obtained for the actual procedure and a separate consent for participation in this study will be attached. Randomization for this study will be via permuted block randomization. The expected 122 patients will be pre-randomized, with the arm for each patient number 1 through 122 sealed in an envelope. After consent is obtained the patient will be assigned the next numerical study identification number and the corresponding envelope will be opened. If the infant has been randomized to the topical liposomal lidocaine group, 1 gram of LMX-4 will be placed over the L3-L4 space immediately, covered with a cotton ball and occlusive tegaderm, for minimum 30 minutes prior to the needle insertion during the lumbar puncture (LP). While the LMX-4 is in place, other procedures that are part of a routine septic work-up may be performed. Thus, the application of this medication should not cause an unnecessary delay in the ultimate procedure or antibiotic administration.

If the infant has been randomized to the subcutaneous lidocaine group, after using sterile procedure to prepare the area, 0.1ml/kg of 1% Lidocaine will be injected using a 25 gauge tuberculin needle over the L3-L4 region. The injection point will be below the actual level desired with the needle going in at a 5-10 degree angle and moving toward the head after insertion. A subcutaneous wheal will form over the desired L3-L4 space when the Lidocaine is injected. The provider will wait at minimum 2 minutes after the injection of the Lidocaine prior to the insertion of the LP needle. Once the required time for local anesthesia in either arm has elapsed, the procedure will be performed with routine technique.

With consent for the video portion of the study, a video camera will be set up to tape the infants face only during the procedure with notation of the LP needle insertion(s). During the procedure, an assistant will record heart rate and oxygen saturation values. The information from the video and documented vital signs will be used to assign a PIPP score by a blinded investigator. Once the procedure is complete the following information will be obtained for study purposes, in addition to the above video tape and vital signs: infant gestational age, infant birth weight, gender, day of life of procedure, level of provider(s) performing the procedure, attempts required to obtain cerebrospinal fluid (CSF) specimen, color of fluid (clear, pink, xanthochromic, or grossly bloody), presence of CSF culture, and Red Blood Cell count of CSF specimen. Infants in our institution will already be monitored continuously and will continue to be so for at minimum 6 hours after the procedure. Any adverse reaction that could be attributed to the procedure or medications used for the procedure will be recorded, with the most expected reaction to be a skin rash. Additional changes in the infant, such as apnea, sustained arrhythmia, oxygen desaturation 10% below baseline, or seizure will also be noted whether or not it is thought to be associated with the procedure.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• neonate requiring lumbar puncture
• gestational age at birth equal to or greater than 34 weeks

Exclusion Criteria:

• on mechanical ventilation
• receiving sedation (opioids or benzodiazepines)
• suspected congenital spinal anomaly
• infants older than 1 week of life

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subcutaneous Lidocaine; 0.1 ml/kg of 1% Lidocaine	Drug: 1% lidocaine; 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure; Other Names: LIDOCAINE
Active Comparator: Topical Lidocaine; LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure	Drug: topical lidocaine; 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure; Other Names: LMX-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar Puncture Success Rate	Success defined as cerebrospinal fluid for a culture and red blood cell count less than 1000	immediately following the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature Infant Pain Profile (PIPP) Score	PIPP score assigned by a blinded outcome assessor by viewing video tapes of the infant's face during the procedure and vital sign changes during that time frame	data collected during the procedure, PIPP score assigned within one month by viewing collected data

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Study Director: Judith J PALAFOUTAS, RN, Georgetown University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 23, 2012
• First Submitted That Met QC Criteria: May 24, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: October 20, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: pain; lidocaine; analgesia; neonate; lumbar puncture; late preterm
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Meningitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: MGUHNICULP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: THERE IS NO DATA TO SHARE