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"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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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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

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Pain

Keywords

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pain lumbar puncture neonates infants emergency department topical anesthesia LMX4

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Drug

Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing

Group Type EXPERIMENTAL

Lidocaine Cream 4%

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

inactive placebo without LMX4

Intervention Type DRUG

Other Intervention Names

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LMX4

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unstable
* Premature (\<37 weeks gestation)
* Allergy to study medicine
* Parent refusal of consent
Minimum Eligible Age

0 Days

Maximum Eligible Age

60 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferndale Laboratories, Inc.

INDUSTRY

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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James Reingold

Principal Investigator

Responsibility Role 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

Site Status

Countries

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United States

Other Identifiers

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05-130

Identifier Type: -

Identifier Source: org_study_id