Trial Outcomes & Findings for "Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age." (NCT NCT00533468)
NCT ID: NCT00533468
Last Updated: 2022-12-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
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
Results posted on
2022-12-28
Participant Flow
Participant milestones
| Measure |
Placebo
patients in this arm were randomized to placebo in a double blind fashion
|
Active Drug
patients in this arm were randomized to receive the active drug, LMX4, in a double blind fashion
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
28
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
patients were randomized to placebo or active drug in a double blind fashion
|
Active Drug
n=24 Participants
patients were randomized to placebo or active drug in a double blind fashion
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=28 Participants
|
24 Participants
n=24 Participants
|
52 Participants
n=52 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
|
Age, Continuous
|
33.6 days
STANDARD_DEVIATION 16.3 • n=28 Participants
|
28.2 days
STANDARD_DEVIATION 14.9 • n=24 Participants
|
31.5 days
STANDARD_DEVIATION 15.4 • n=52 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=28 Participants
|
12 Participants
n=24 Participants
|
23 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=28 Participants
|
12 Participants
n=24 Participants
|
29 Participants
n=52 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=28 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=28 Participants
|
6 Participants
n=24 Participants
|
12 Participants
n=52 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=28 Participants
|
6 Participants
n=24 Participants
|
24 Participants
n=52 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=28 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
24 participants
n=24 Participants
|
52 participants
n=52 Participants
|
|
gestational age
|
39.4 weeks
STANDARD_DEVIATION 1.3 • n=28 Participants
|
38.8 weeks
STANDARD_DEVIATION 1.2 • n=24 Participants
|
39 weeks
STANDARD_DEVIATION 1.2 • n=52 Participants
|
|
WEIGHT
|
5094 GRAMS
STANDARD_DEVIATION 2147 • n=28 Participants
|
4492 GRAMS
STANDARD_DEVIATION 1387 • n=24 Participants
|
4708 GRAMS
STANDARD_DEVIATION 1651 • n=52 Participants
|
PRIMARY outcome
Timeframe: 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 swaddledPopulation: infants 0-60 days
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
Outcome measures
| Measure |
Placebo
n=28 Participants
patients were randomized to placebo in this arm in a double blind fashion
|
Active Drug
n=24 Participants
patients were randomized active drug in this arm in a double blind fashion
|
|---|---|---|
|
Neonatal Facial Coding System Score
Baseline
|
4.6 score on a scale
Standard Deviation 4
|
3.9 score on a scale
Standard Deviation 3.5
|
|
Neonatal Facial Coding System Score
Positioning
|
8.3 score on a scale
Standard Deviation 5
|
8 score on a scale
Standard Deviation 4.5
|
|
Neonatal Facial Coding System Score
Pre-needle
|
7.6 score on a scale
Standard Deviation 6
|
6.7 score on a scale
Standard Deviation 5
|
|
Neonatal Facial Coding System Score
Needle Insertion
|
9.3 score on a scale
Standard Deviation 6
|
9.9 score on a scale
Standard Deviation 5.5
|
|
Neonatal Facial Coding System Score
Post-needle Insertion
|
5.7 score on a scale
Standard Deviation 6.5
|
6.1 score on a scale
Standard Deviation 6
|
|
Neonatal Facial Coding System Score
Post-procedure
|
4.2 score on a scale
Standard Deviation 8.5
|
5.9 score on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Infant's stay in the Emergency DepartmentPopulation: infants 0-60 days of age
Time, measured in minutes, required to complete procedure from infant's presentation to the Emergency Department
Outcome measures
| Measure |
Placebo
n=28 Participants
patients were randomized to placebo in this arm in a double blind fashion
|
Active Drug
n=24 Participants
patients were randomized active drug in this arm in a double blind fashion
|
|---|---|---|
|
Time of Procedure
|
31 minutes
Standard Deviation 12
|
36 minutes
Standard Deviation 16
|
SECONDARY outcome
Timeframe: During patient's Emergency Department StayWhether the Lumbar Puncture resulted in recovery of spinal fluid that could be sent for usual testing
Outcome measures
| Measure |
Placebo
n=28 Participants
patients were randomized to placebo in this arm in a double blind fashion
|
Active Drug
n=24 Participants
patients were randomized active drug in this arm in a double blind fashion
|
|---|---|---|
|
Percentage of Procedures With Success
|
96 percentage of procedures
|
75 percentage of procedures
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Active Drug
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Patients in this arm were administered placebo without active drug
|
Active Drug
n=24 participants at risk
patients in this arm were administered active drug
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
35.7%
10/28 • Number of events 10
|
16.7%
4/24 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place