Trial Outcomes & Findings for Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures (NCT NCT01516684)

Last Updated: 2019-09-06

Results Overview

Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

20 minutes after sedation

Results posted on

2019-09-06

Participant Flow

Originally 33 participants were registered, with 170 trials; each participant had between 1-14 trials (median=4). Five of these participants did not end up receiving the procedure and 1 was a screen fail, leaving 27 participants with between 1-14 trials (median=5).

Unit of analysis: Trials

Participant milestones

Participant milestones
Measure	Arm A (EMLA) Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation	Arm B (Placebo) Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation
Overall Study STARTED	0 85	0 85
Overall Study COMPLETED	0 75	0 77
Overall Study NOT COMPLETED	0 10	0 8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (EMLA) n=75 Trials Trials completed is the unit of measure, not participants. Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation	Arm B (Placebo) n=77 Trials Trials completed is the unit of measure, not participants. Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation	Total n=152 Trials Total of all reporting groups
Age, Continuous	7.7 years STANDARD_DEVIATION 5.4 • n=75 Trials	8.8 years STANDARD_DEVIATION 5.3 • n=77 Trials	8.2 years STANDARD_DEVIATION 5.4 • n=152 Trials
Sex: Female, Male Female	22 Trials n=75 Trials	22 Trials n=77 Trials	44 Trials n=152 Trials
Sex: Female, Male Male	53 Trials n=75 Trials	55 Trials n=77 Trials	108 Trials n=152 Trials
Ethnicity (NIH/OMB) Hispanic or Latino	10 Trials n=75 Trials	10 Trials n=77 Trials	20 Trials n=152 Trials
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Trials n=75 Trials	67 Trials n=77 Trials	132 Trials n=152 Trials
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Trials n=75 Trials	0 Trials n=77 Trials	0 Trials n=152 Trials
Race (NIH/OMB) American Indian or Alaska Native	0 Trials n=75 Trials	0 Trials n=77 Trials	0 Trials n=152 Trials
Race (NIH/OMB) Asian	0 Trials n=75 Trials	0 Trials n=77 Trials	0 Trials n=152 Trials
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Trials n=75 Trials	0 Trials n=77 Trials	0 Trials n=152 Trials
Race (NIH/OMB) Black or African American	14 Trials n=75 Trials	18 Trials n=77 Trials	32 Trials n=152 Trials
Race (NIH/OMB) White	60 Trials n=75 Trials	56 Trials n=77 Trials	116 Trials n=152 Trials
Race (NIH/OMB) More than one race	1 Trials n=75 Trials	3 Trials n=77 Trials	4 Trials n=152 Trials
Race (NIH/OMB) Unknown or Not Reported	0 Trials n=75 Trials	0 Trials n=77 Trials	0 Trials n=152 Trials
Region of Enrollment United States	75 Trials completed n=75 Trials	77 Trials completed n=77 Trials	152 Trials completed n=152 Trials

PRIMARY outcome

Timeframe: 20 minutes after sedation

Population: Participants were not randomized. Trials were randomized so we will have to use the trials to report by arm

Outcome measures

Outcome measures
Measure	Arm A (EMLA) n=75 Trials Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation	Arm B (Placebo) n=77 Trials Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation
Total Dose of Propofol Administered to Each Patient	2.94 mg/kg Standard Error 0.25	3.22 mg/kg Standard Error 0.19

SECONDARY outcome

Timeframe: At the time of LP insertion

Population: Participants were not randomized. Trials were randomized so we will use the trials to report by arm

Outcome measures

Outcome measures
Measure	Arm A (EMLA) n=75 Trials Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation	Arm B (Placebo) n=77 Trials Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation
Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration No movement	50 Trials	29 Trials
Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration Minor movement	7 Trials	12 Trials
Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration Major movement	8 Trials	27 Trials
Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration Other	10 Trials	9 Trials

SECONDARY outcome

Timeframe: Within one week of the LP

Population: Not all procedures were completed at all trials. Participants were not randomized. Trials were randomized so will use the trials to report by arm.

Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any headache after the lumbar puncture, and if they had any other complications.

Outcome measures

Outcome measures
Measure	Arm A (EMLA) n=68 Trials Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation	Arm B (Placebo) n=73 Trials Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation
Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, as Well as Post-LP Headache From Sedation With or Without EMLA Cream	0.194 Probability of experiencing headache Standard Error 0.041	0.289 Probability of experiencing headache Standard Error 0.057

SECONDARY outcome

Timeframe: 20 minutes after lumbar puncture

Population: Total number of trials was 136, 15 are missing. Participants were not randomized. Trials were randomized so will use the trials to report by arm.

Traumatic lumbar puncture is defined as lumbar puncture in which cerebrospinal fluid contains at least 10 red blood cells (RBCs) per microliter and bloody lumbar as one in which the cerebrospinal fluid contained at least 500 red blood cells (RBCs) per microliter.

Outcome measures

Outcome measures
Measure	Arm A (EMLA) n=70 Trials Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation	Arm B (Placebo) n=66 Trials Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation
Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration Atraumatic	63 Trials	57 Trials
Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration Traumatic	6 Trials	5 Trials
Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration Bloody	1 Trials	4 Trials

SECONDARY outcome

Timeframe: Within one week of the LP

Population: Not all procedures were completed at all trials. Participants were not randomized. Trials were randomized so will use the trials to report by arm.

Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any back pain after the lumbar puncture, and if they had any other complications.

Outcome measures

Outcome measures
Measure	Arm A (EMLA) n=69 Trials Patients receive topical EMLA cream 60 minutes to 4 hours prior to the lumbar puncture followed by standard sedation	Arm B (Placebo) n=74 Trials Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation
Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream	0.211 Probability of experiencing back pain Standard Error 0.049	0.250 Probability of experiencing back pain Standard Error 0.054

Adverse Events

Arm A (EMLA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas McLean

Wake Forest University Health Sciences

Phone: 336-716-5440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place