Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain

NCT01606150 | Terminated Results DMC

• 1 other identifier: MGUHNICULP
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meningitis

Keywords

neonate; late preterm; lumbar puncture; analgesia; pain; lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Premature Infant Pain Profile (PIPP) Score

  data collected during the procedure, PIPP score assigned within one month by viewing collected data

Study Arms (2)

Subcutaneous Lidocaine

ACTIVE COMPARATOR

0.1 ml/kg of 1% Lidocaine

Drug: 1% lidocaine

Topical Lidocaine

ACTIVE COMPARATOR

LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure

Drug: topical lidocaine

Interventions

1% lidocaine DRUG

0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure

Also known as: LIDOCAINE

Subcutaneous Lidocaine

topical lidocaine DRUG

1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure

Also known as: LMX-4

Topical Lidocaine

Eligibility Criteria

• Age: Up to 8 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Meningitis; Agnosia; Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

This study proved to be very difficult to execute in a busy NICU due to clinical practice biases and technical difficulties in establishing masked treatment. The Investigator left the Fellowship program before any results could be analyzed.

Results Point of Contact

• Title: Judith Palafoutas, Research Director
• Organization: Georgetown University NICU

jxp11@gunet.georgetown.edu

202 444 8756

Study Officials

• Judith J PALAFOUTAS, RN

  Georgetown University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 25, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 13, 2016
• Results First Posted: December 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)