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| Name | Class |
|---|---|
| Ferndale Laboratories, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Drug | Experimental | Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing |
|
| Placebo | Placebo Comparator | Placebo Cream made on same run at factory but without active Lidocaine 4% drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine Cream 4% | Drug | Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Procedure | Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department | Infant's stay in the Emergency Department |
| Percentage of Procedures With Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James L Reingold, MD | SUNY Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's and Children's Hospital of Buffalo | Buffalo | New York | 14222 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | patients in this arm were randomized to placebo in a double blind fashion |
| FG001 | Active Drug | patients in this arm were randomized to receive the active drug, LMX4, in a double blind fashion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | patients were randomized to placebo or active drug in a double blind fashion |
| BG001 | Active Drug | patients were randomized to placebo or active drug in a double blind fashion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | infants 0-60 days | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients in this arm were administered placebo without active drug | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr James Reingold | Children's Hospital of Philadelphia | 6027516093 | reingoldj@email.chop.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| Placebo | Drug | inactive placebo without LMX4 |
|
Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing
| During patient's Emergency Department Stay |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| gestational age | Mean | Standard Deviation | weeks |
|
| WEIGHT | Mean | Standard Deviation | GRAMS |
|
|
|
| Secondary | Time of Procedure | Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department | infants 0-60 days of age | Posted | Mean | Standard Deviation | minutes | Infant's stay in the Emergency Department |
|
|
|
| Secondary | Percentage of Procedures With Success | Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing | Posted | Number | percentage of procedures | During patient's Emergency Department Stay |
|
|
|
| 28 |
| 0 |
| 28 |
| 10 |
| 28 |
| EG001 | Active Drug | patients in this arm were administered active drug | 0 | 24 | 0 | 24 | 4 | 24 |
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| D010335 | Pathologic Processes |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|