PainPhase 4NCT00533468

"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."

A Phase 4 study testing Lidocaine Cream 4% in people with Pain, run by State University of New York at Buffalo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap). Read more about this study

Who is it for?: Ages 0 to 60 days
Conditions the study is for: Pain
What is being tested?: Lidocaine Cream 4%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteUnited States
Study dates: Mar 2007to Mar 2008
Phase: Phase 4
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 0 to 60 days
All sexes
No healthy volunteers
Child

Who may be able to join

Full term (>=37 weeks gestation)
Age 0-60 Days
Undergoing Lumbar Puncture

Who cannot join

Unstable
Premature (<37 weeks gestation)
Allergy to study medicine
Parent refusal of consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Women's and Children's Hospital of Buffalo
Buffalo, New York, 14222

Other trials in United States

About this study

The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).

Read the detailed description

Pain of infants will be measured using the Neonatal Facial Coding System by videotaping the infant's face while they undergo the procedure. A comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the procedure of the infants.

Conditions: Pain
Being tested: Lidocaine Cream 4%, Placebo
Keywords: pain, lumbar puncture, neonates, infants, emergency department, topical anesthesia, LMX4
Medical subject headings: Pain, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidocaine Cream 4%Drug
Also called LMX4
Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
PlaceboDrug
inactive placebo without LMX4

Study groups in NCT00533468
Study group	Role	What they receive
Active Drug	Experimental	Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing Receives: Drug: Lidocaine Cream 4%
Placebo	Placebo comparator	Placebo Cream made on same run at factory but without active Lidocaine 4% drug Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Neonatal Facial Coding System Score
10 measures of pain, all scored 0 or 1, high score means more pain. No pain would be recorded as zero, maximum pain recorded as 10
Measured: Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled

Secondary outcomes (2)

Time of Procedure
Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department
Measured: Infant's stay in the Emergency Department
Percentage of Procedures With Success
Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing
Measured: During patient's Emergency Department Stay

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Mar 2008

First posted21 Sep 2007 (estimated)
Study startMar 2007
Primary completionMar 2008
Study completionMar 2008

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 PainStudies of the same condition, open and under way.
More trials run by State University of New York at BuffaloThe 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 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00533468
Sponsor's protocol ID: 05-130
Status last verified: Nov 2022
First submitted: 19 Sep 2007
Last updated: 28 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
ClinicalTrials.gov ID: NCT00533468
Acronym / sponsor ID: 05-130
Conditions: Pain
Keywords: pain, lumbar puncture, neonates, infants, emergency department, topical anesthesia, LMX4
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: State University of New York at BuffaloUniversity, hospital or other
Collaborators: Ferndale Laboratories, Inc.
Study start: Mar 2007
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 21 Sep 2007 (estimated)
Results: Posted 28 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active Drug	Experimental	Drug: Lidocaine Cream 4%Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing
Placebo	Placebo comparator	Drug: PlaceboPlacebo Cream made on same run at factory but without active Lidocaine 4% drug

Who may qualify

Ages: 0 to 60 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Full term (>=37 weeks gestation)
Age 0-60 Days
Undergoing Lumbar Puncture

Key exclusion criteria (4 listed)

Unstable
Premature (<37 weeks gestation)
Allergy to study medicine
Parent refusal of consent

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
Lidocaine Cream 4%Also: LMX4Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure	Drug	Active Drug
Placeboinactive placebo without LMX4	Drug	Placebo

Primary outcome

Neonatal Facial Coding System Score
Time frame: Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled
10 measures of pain, all scored 0 or 1, high score means more pain. No pain would be recorded as zero, maximum pain recorded as 10

2 secondary outcomes

Time of Procedure
Time frame: Infant's stay in the Emergency Department
Percentage of Procedures With Success
Time frame: During patient's Emergency Department Stay

Results and safety

Results posted to the registry on 28 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	35	28
Active Drug	35	24

Primary outcome: Neonatal Facial Coding System Score

Time frame: Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 28	Active Drug n = 24
Baseline	4.6 (4)	3.9 (3.5)
Positioning	8.3 (5)	8 (4.5)
Pre-needle	7.6 (6)	6.7 (5)
Needle Insertion	9.3 (6)	9.9 (5.5)
Post-needle Insertion	5.7 (6.5)	6.1 (6)
Post-procedure	4.2 (8.5)	5.9 (8)

Population analysed: infants 0-60 days

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 28 (0%)	10 of 28 (35.7%)	0 of 28
Active Drug	0 of 24 (0%)	4 of 24 (16.7%)	0 of 24

Limitations and caveats (from the sponsor): Significant technical limitation was encountered regarding videotaping of infant faces when properly positioned for the procedure, as the research assistant had to be underneath the nurse's arm with the camera adjacent to the nurse's breast. This resulted in many exclusions of patients enrolled by the male research assistants as the camera was not in proper position. The many exclusions reduced the study's power to reach a statistically significant difference.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

James L Reingold, MD principal investigator

SUNY Buffalo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine Cream 4% in people with Pain, run by State University of New York at Buffalo 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 3 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: finished, as of the sponsor's last update on 28 Dec 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2022). 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?

Neonatal Facial Coding System Score (time frame: Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00533468.

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 28 Dec 2022.