A Phase 2 interventional study of placebo administration and EMLA in Malignant Neoplasm, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged Up to 22 Years. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Supportive care
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
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.
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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
Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
Drug: EMLA · Drug: propofol · Drug: fentanyl citrate
Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
Drug: placebo administration · Drug: propofol · Drug: fentanyl citrate
Given topically
Given topically
Also known as: eutectic mixture of local anesthetics, lidocaine-prilocaine, lidocaine-prilocaine eutectic mixture
Given IV
Also known as: Diprivan
Given IV
Also known as: Actiq, Oralet, Sublimaze
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
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
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
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
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
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).
| Milestone | Arm A (EMLA) | Arm B (Placebo) |
|---|---|---|
| Started | NA | NA |
| Completed | NA | NA |
| Not completed | NA | NA |
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.
| mg/kg | Arm A (EMLA) | Arm B (Placebo) |
|---|---|---|
| Total Dose of Propofol Administered to Each Patient | 2.94 ± 0.25 | 3.22 ± 0.19 |
| Trials | Arm A (EMLA) | Arm B (Placebo) |
|---|---|---|
| No movement | 50 | 29 |
| Minor movement | 7 | 12 |
| Major movement | 8 | 27 |
| Other | 10 | 9 |
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.
| Probability of experiencing headache | Arm A (EMLA) | 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 | 0.194 ± 0.041 | 0.289 ± 0.057 |
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.
| Trials | Arm A (EMLA) | Arm B (Placebo) |
|---|---|---|
| Atraumatic | 63 | 57 |
| Traumatic | 6 | 5 |
| Bloody | 1 | 4 |
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.
| Probability of experiencing back pain | Arm A (EMLA) | 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 | 0.211 ± 0.049 | 0.250 ± 0.054 |
Collected over Up to one week after lumbar puncture. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A (EMLA) | 0/75 (0%) | 0/75 (0%) | 0/75 (0%) |
| Arm B (Placebo) | 0/77 (0%) | 0/77 (0%) | 0/77 (0%) |
Participants were not randomized to the arms. The trials for each arm were randomized so we are using the trials to report demographics by arm.
| Age, Continuous(years) | Arm A (EMLA) | Arm B (Placebo) | Total |
|---|---|---|---|
| Mean | 7.7 ± 5.4 | 8.8 ± 5.3 | 8.2 ± 5.4 |
| Sex: Female, Male(Trials) | Arm A (EMLA) | Arm B (Placebo) | Total |
|---|---|---|---|
| Female | 22 | 22 | 44 |
| Male | 53 | 55 | 108 |
| Ethnicity (NIH/OMB)(Trials) | Arm A (EMLA) | Arm B (Placebo) | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 10 | 20 |
| Not Hispanic or Latino | 65 | 67 | 132 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Trials) | Arm A (EMLA) | Arm B (Placebo) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 14 | 18 | 32 |
| White | 60 | 56 | 116 |
| More than one race | 1 | 3 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Trials completed) | Arm A (EMLA) | Arm B (Placebo) | Total |
|---|---|---|---|
| United States | 75 | 77 | 152 |
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Wake Forest University Health Sciences