"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
NCT ID: NCT00533468
Last Updated: 2022-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2007-03-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Active Drug
Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing
Lidocaine Cream 4%
Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
Placebo
Placebo Cream made on same run at factory but without active Lidocaine 4% drug
Placebo
inactive placebo without LMX4
Interventions
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Lidocaine Cream 4%
Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
Placebo
inactive placebo without LMX4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 0-60 Days
* Undergoing Lumbar Puncture
Exclusion Criteria
* Premature (\<37 weeks gestation)
* Allergy to study medicine
* Parent refusal of consent
0 Days
60 Days
ALL
No
Sponsors
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Ferndale Laboratories, Inc.
INDUSTRY
State University of New York at Buffalo
OTHER
Responsible Party
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James Reingold
Principal Investigator
Principal Investigators
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James L Reingold, MD
Role: PRINCIPAL_INVESTIGATOR
SUNY Buffalo
Locations
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Women's and Children's Hospital of Buffalo
Buffalo, New York, United States
Countries
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Other Identifiers
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05-130
Identifier Type: -
Identifier Source: org_study_id
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