Malignant Neoplasm
Conditions
Brief summary
This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary
Detailed description
PRIMARY OBJECTIVES: I. To determine whether the application of a topical anesthetic (EMLA cream) to the LP site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for LPs compared to application of a topical placebo cream. SECONDARY OBJECTIVES: I. To determine whether the use of EMLA cream decreases complication rates from sedation. II. To determine whether the use of EMLA cream decreases traumatic lumbar punctures. III. To determine whether the use of EMLA cream shortens recovery time. IV. To determine practitioner and parent satisfaction with the use of EMLA cream. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol. ARM II: Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol. After completion of study treatment, patients are followed up within 1 week.
Interventions
DRUGplacebo administration
Given topically
DRUGEMLA
Given topically
DRUGpropofol
Given IV
DRUGfentanyl citrate
Given IV
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 22 Years
Healthy volunteers
No
Inclusion criteria
Pediatric oncology patients undergoing a lumbar puncture in the Pediatric Sedation Suite; patients may or may not be receiving intrathecal chemotherapy
Exclusion criteria
Patients undergoing additional procedures during the same anesthetic such as bone marrow aspirate or biopsy will be excluded because they will likely require higher doses of propofol than those undergoing LP alone Patients who are allergic to or not tolerant of EMLA cream, propofol, or fentanyl will be excluded Patients who are pregnant will be excluded Patients having their LPs done by students will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Dose of Propofol Administered to Each Patient | 20 minutes after sedation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration | At the time of LP insertion | — |
| 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 | Within one week of the LP | 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. |
| Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration | 20 minutes after lumbar puncture | 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. |
| 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 | Within one week of the LP | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Arm A (EMLA) 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 | 0 |
| Arm A (EMLA) 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 | 75 |
| Arm B (Placebo) 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 | 0 |
| Arm B (Placebo) 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 | 77 |
| Total | 152 |
Baseline characteristics
| Characteristic | Arm A (EMLA) | Total | Arm B (Placebo) |
|---|---|---|---|
| Age, Continuous | 7.7 years STANDARD_DEVIATION 5.4 | 8.2 years STANDARD_DEVIATION 5.4 | 8.8 years STANDARD_DEVIATION 5.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Trials | 20 Trials | 10 Trials |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Trials | 132 Trials | 67 Trials |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Trials | 0 Trials | 0 Trials |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Trials | 0 Trials | 0 Trials |
| Race (NIH/OMB) Asian | 0 Trials | 0 Trials | 0 Trials |
| Race (NIH/OMB) Black or African American | 14 Trials | 32 Trials | 18 Trials |
| Race (NIH/OMB) More than one race | 1 Trials | 4 Trials | 3 Trials |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Trials | 0 Trials | 0 Trials |
| Race (NIH/OMB) Unknown or Not Reported | 0 Trials | 0 Trials | 0 Trials |
| Race (NIH/OMB) White | 60 Trials | 116 Trials | 56 Trials |
| Region of Enrollment United States | 75 Trials completed | 152 Trials completed | 77 Trials completed |
| Sex: Female, Male Female | 22 Trials | 44 Trials | 22 Trials |
| Sex: Female, Male Male | 53 Trials | 108 Trials | 55 Trials |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 77 |
| other Total, other adverse events | 0 / 75 | 0 / 77 |
| serious Total, serious adverse events | 0 / 75 | 0 / 77 |
Outcome results
Primary
Total Dose of Propofol Administered to Each Patient
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.
Time frame: 20 minutes after sedation
Population: Participants were not randomized. Trials were randomized so we will have to use the trials to report by arm
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm A (EMLA) | Total Dose of Propofol Administered to Each Patient | 2.94 mg/kg | Standard Error 0.25 |
| Arm B (Placebo) | Total Dose of Propofol Administered to Each Patient | 3.22 mg/kg | Standard Error 0.19 |
Comparison: 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 for the outcome. GEE methods will be used when analyzing the percentage of times additional propofol was administered. Mixed model regression methods will be used when analyzing the total dose administered.p-value: 0.036T-test and chi-square
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (EMLA) | 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 |
| Arm B (Placebo) | 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 | 0.289 Probability of experiencing headache | Standard Error 0.057 |
p-value: 0.094Mixed Models Analysis
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A (EMLA) | 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 |
| Arm B (Placebo) | 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 | 0.250 Probability of experiencing back pain | Standard Error 0.054 |
p-value: 0.426Mixed Models Analysis
Secondary
Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration
Time frame: At the time of LP insertion
Population: Participants were not randomized. Trials were randomized so we will use the trials to report by arm
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Arm A (EMLA) | Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration | No movement | 50 Trials |
| Arm A (EMLA) | Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration | Minor movement | 7 Trials |
| Arm A (EMLA) | Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration | Major movement | 8 Trials |
| Arm A (EMLA) | Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration | Other | 10 Trials |
| Arm B (Placebo) | Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration | Other | 9 Trials |
| Arm B (Placebo) | Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration | No movement | 29 Trials |
| Arm B (Placebo) | Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration | Major movement | 27 Trials |
| Arm B (Placebo) | Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration | Minor movement | 12 Trials |
Secondary
Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Arm A (EMLA) | Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration | Atraumatic | 63 Trials |
| Arm A (EMLA) | Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration | Traumatic | 6 Trials |
| Arm A (EMLA) | Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration | Bloody | 1 Trials |
| Arm B (Placebo) | Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration | Atraumatic | 57 Trials |
| Arm B (Placebo) | Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration | Traumatic | 5 Trials |
| Arm B (Placebo) | Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration | Bloody | 4 Trials |
p-value: 0.382Chi-squared