Pain
Conditions
Keywords
pain, lumbar puncture, neonates, infants, emergency department, topical anesthesia, LMX4
Brief summary
The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).
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.
Interventions
DRUGLidocaine Cream 4%
Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure
DRUGPlacebo
inactive placebo without LMX4
Sponsors
Ferndale Laboratories, Inc.
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to 60 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Facial Coding System Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Procedure | Infant's stay in the Emergency Department | Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department |
| Percentage of Procedures With Success | During patient's Emergency Department Stay | Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo patients were randomized to placebo or active drug in a double blind fashion | 28 |
| Active Drug patients were randomized to placebo or active drug in a double blind fashion | 24 |
| Total | 52 |
Baseline characteristics
| Characteristic | Active Drug | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 24 Participants | 28 Participants | 52 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 28.2 days STANDARD_DEVIATION 14.9 | 33.6 days STANDARD_DEVIATION 16.3 | 31.5 days STANDARD_DEVIATION 15.4 |
| gestational age | 38.8 weeks STANDARD_DEVIATION 1.2 | 39.4 weeks STANDARD_DEVIATION 1.3 | 39 weeks STANDARD_DEVIATION 1.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 6 Participants | 18 Participants | 24 Participants |
| Region of Enrollment United States | 24 participants | 28 participants | 52 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 29 Participants |
| WEIGHT | 4492 GRAMS STANDARD_DEVIATION 1387 | 5094 GRAMS STANDARD_DEVIATION 2147 | 4708 GRAMS STANDARD_DEVIATION 1651 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 24 |
| other Total, other adverse events | 10 / 28 | 4 / 24 |
| serious Total, serious adverse events | 0 / 28 | 0 / 24 |
Outcome results
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
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
Population: infants 0-60 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Neonatal Facial Coding System Score | Pre-needle | 7.6 score on a scale | Standard Deviation 6 |
| Placebo | Neonatal Facial Coding System Score | Baseline | 4.6 score on a scale | Standard Deviation 4 |
| Placebo | Neonatal Facial Coding System Score | Needle Insertion | 9.3 score on a scale | Standard Deviation 6 |
| Placebo | Neonatal Facial Coding System Score | Positioning | 8.3 score on a scale | Standard Deviation 5 |
| Placebo | Neonatal Facial Coding System Score | Post-needle Insertion | 5.7 score on a scale | Standard Deviation 6.5 |
| Placebo | Neonatal Facial Coding System Score | Post-procedure | 4.2 score on a scale | Standard Deviation 8.5 |
| Active Drug | Neonatal Facial Coding System Score | Post-procedure | 5.9 score on a scale | Standard Deviation 8 |
| Active Drug | Neonatal Facial Coding System Score | Post-needle Insertion | 6.1 score on a scale | Standard Deviation 6 |
| Active Drug | Neonatal Facial Coding System Score | Positioning | 8 score on a scale | Standard Deviation 4.5 |
| Active Drug | Neonatal Facial Coding System Score | Pre-needle | 6.7 score on a scale | Standard Deviation 5 |
| Active Drug | Neonatal Facial Coding System Score | Needle Insertion | 9.9 score on a scale | Standard Deviation 5.5 |
| Active Drug | Neonatal Facial Coding System Score | Baseline | 3.9 score on a scale | Standard Deviation 3.5 |
Secondary
Percentage of Procedures With Success
Whether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing
Time frame: During patient's Emergency Department Stay
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Procedures With Success | 96 percentage of procedures |
| Active Drug | Percentage of Procedures With Success | 75 percentage of procedures |
Secondary
Time of Procedure
Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department
Time frame: Infant's stay in the Emergency Department
Population: infants 0-60 days of age
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time of Procedure | 31 minutes | Standard Deviation 12 |
| Active Drug | Time of Procedure | 36 minutes | Standard Deviation 16 |