MeningitisNCT01606150
Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain
A study testing 1% lidocaine and topical lidocaine in people with Meningitis, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Meningitis
- What is being tested?
- 1% lidocaine and topical lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 8 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- neonate requiring lumbar puncture
- gestational age at birth equal to or greater than 34 weeks
Who cannot join
- on mechanical ventilation
- receiving sedation (opioids or benzodiazepines)
- suspected congenital spinal anomaly
- infants older than 1 week of life
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
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.
Read the 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.
- Conditions
- Meningitis
- Being tested
- 1% lidocaine, topical lidocaine
- Keywords
- neonate, late preterm, lumbar puncture, analgesia, pain, lidocaine
- Medical subject headings
- Meningitis, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% lidocaineDrug
Also called LIDOCAINE
0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure
topical lidocaineDrug
Also called LMX-4
1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Lidocaine | Active comparator | 0.1 ml/kg of 1% Lidocaine Receives: Drug: 1% lidocaine |
| Topical Lidocaine | Active comparator | LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure Receives: Drug: topical lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Puncture Success Rate
Success defined as cerebrospinal fluid for a culture and red blood cell count less than 1000
Measured: immediately following the procedure
Secondary outcomes (1)
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
Measured: data collected during the procedure, PIPP score assigned within one month by viewing collected data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Investigator left the insititution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney DeJesso, MD, Georgetown University
- Investigators
- Judith J PALAFOUTAS, RN, Study director, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606150
- Sponsor's protocol ID
- MGUHNICULP
- Status last verified
- Oct 2016
- First submitted
- 23 May 2012
- Last updated
- 13 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: THERE IS NO DATA TO SHARE
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain
- ClinicalTrials.gov ID
- NCT01606150
- Acronym / sponsor ID
- MGUHNICULP
- Conditions
- Meningitis
- Keywords
- neonate, late preterm, lumbar puncture, analgesia, pain, lidocaine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left the insititution
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 13 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Lidocaine | Active comparator | Drug: 1% lidocaine0.1 ml/kg of 1% Lidocaine |
| Topical Lidocaine | Active comparator | Drug: topical lidocaineLMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- neonate requiring lumbar puncture
- gestational age at birth equal to or greater than 34 weeks
Key exclusion criteria (4 listed)
- on mechanical ventilation
- receiving sedation (opioids or benzodiazepines)
- suspected congenital spinal anomaly
- infants older than 1 week of life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% lidocaineAlso: LIDOCAINE0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure | Drug | Subcutaneous Lidocaine |
| topical lidocaineAlso: LMX-41 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure | Drug | Topical Lidocaine |
Primary outcome
Lumbar Puncture Success Rate
Time frame: immediately following the procedure
Success defined as cerebrospinal fluid for a culture and red blood cell count less than 1000
1 secondary outcome
Premature Infant Pain Profile (PIPP) Score
Time frame: data collected during the procedure, PIPP score assigned within one month by viewing collected data
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. THERE IS NO DATA TO SHARE
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith J PALAFOUTAS, RN study director
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1% lidocaine and topical lidocaine in people with Meningitis, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Puncture Success Rate (time frame: immediately following the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.