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A common procedure in children with cancer is the spinal tap, or lumbar puncture (LP), in which a needle is inserted into the spinal canal. In this population, LPs are most commonly performed to collect cerebrospinal fluid (CSF, the liquid surrounding the brain and spinal cord) for diagnostic testing, and to inject medications including chemotherapy. Local analgesic (pain control medicine) during pediatric LP procedures is underutilized and not standardized. The first local analgesic routinely used for LP procedures was lidocaine injection. The discovery of the topical EMLA (lidocaine 2.5%/prilocaine 2.5%) cream, approved by the FDA for local skin use in pediatric patients, has provided an additional option for local LP analgesia. A comparison between topical EMLA vs lidocaine injection for LP pain control in the pediatric population has not been performed. Pediatric oncology patients often require serial LPs for diagnostics purposes and/or chemotherapy delivery. Due to a lack of standardization of LP analgesia in this population, the investigators have designed a prospective, single-blind, randomized control crossover trial to examine EMLA vs. lidocaine injection in reducing pain associated with LP in children being treated for leukemia or lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMLA | Active Comparator | The patient will receive 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. The site of EMLA application will be covered with Tegaderm dressing. |
|
| Lidocaine | Active Comparator | The patient will receive sham-EMLA cream (a fragrance-free hypoallergenic moisturizer cream) will be applied at least 60 minutes per standard protocol with Tegaderm dressing.- Following conscious sedation, the patient will receive lidocaine 1% injection (~1-2ml) at the appropriate site 30-60 seconds prior to LP needle insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMLA | Drug | EMLA cream (lidocaine 2.5% and prilocaine 2.5%) |
| |
| Lidocaine |
| Measure | Description | Time Frame |
|---|---|---|
| Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale | Pain was self-reported by the child using the validated pain scale, Wong-Baker Faces Pain Rating Scale. The scale shows a series of six faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain, with higher the number, greater the pain. Below are the median and range of values (minimal to maximal) reported by each arm's 10 patients. Reported values were identical between arms. | , pain will be assessed at 30 - 60 minutes after waking up after lumbar puncture and 24 hours after lumbar puncture |
| Measure | Description | Time Frame |
|---|---|---|
| Post Lumbar Puncture PRN Pain Medication Usage | Use of PRN or "as needed" pain medicine by the patient was determined. Patients with parent/guardian assistance were asked to record the "as needed" pain control medication, acetaminophen. the patient used within the 24 hours after lumber puncture. Counts of patients using acetaminophen in the 24 hours following lumber puncture are reported. | 24 hours following lumbar puncture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamad Badawi, MD | WVU-Charleston and CAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAMC - Women and Children's Hospital | Charleston | West Virginia | 25302 | United States |
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10 patients were screen and enrolled in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | EMLA for First Lumbar Puncture, Lidocaine Injection for Second Lumbar Puncture | First lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. Subsequent lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion. |
| FG001 | Lidocaine Injection for First Lumbar Puncture, EMLA for Second Lumbar Puncture | First lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion. the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. Subsequent lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EMLA for First Lumbar Puncture, Lidocaine Injection for Second Lumbar Puncture | First lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. Subsequent lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale | Pain was self-reported by the child using the validated pain scale, Wong-Baker Faces Pain Rating Scale. The scale shows a series of six faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain, with higher the number, greater the pain. Below are the median and range of values (minimal to maximal) reported by each arm's 10 patients. Reported values were identical between arms. | Posted | Median | Full Range | score on a scale | , pain will be assessed at 30 - 60 minutes after waking up after lumbar puncture and 24 hours after lumbar puncture |
|
7 days for each intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EMLA | Participants who received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure, either the first or second lumbar puncture included in the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Thompson | CAMC Institute of Academic Medicine | 304-388-9911 | stethompson@camc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2019 | Sep 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
lidocaine 1% |
|
| BG001 | Lidocaine Injection for First Lumbar Puncture, EMLA for Second Lumbar Puncture | First lumbar puncture: patient received sham-EMLA cream applied at least 60 minutes prior to procedure. Following conscious sedation, the patient received lidocaine 1% injection (~1-2ml) 30-60 seconds prior to lumbar puncture needle insertion. the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. Subsequent lumbar puncture: the participant received 5 grams EMLA cream at the site of the lumbar puncture at least 60 minutes prior to procedure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Lidocaine Injection | Participants who received sham-EMLA cream (applied at least 60 minutes prior to procedure) and following conscious sedation, the patient received lidocaine 1% injection (~1-2ml) at the appropriate site 30-60 seconds prior to prior to procedure, either the first or second lumbar puncture included in the study. |
|
|
| Secondary | Post Lumbar Puncture PRN Pain Medication Usage | Use of PRN or "as needed" pain medicine by the patient was determined. Patients with parent/guardian assistance were asked to record the "as needed" pain control medication, acetaminophen. the patient used within the 24 hours after lumber puncture. Counts of patients using acetaminophen in the 24 hours following lumber puncture are reported. | Posted | Count of Participants | Participants | 24 hours following lumbar puncture |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Lidocaine Injection | Participants who received sham-EMLA cream (applied at least 60 minutes prior to procedure) and following conscious sedation, the patient received lidocaine 1% injection (~1-2ml) at the appropriate site 30-60 seconds prior to prior to procedure, either the first or second lumbar puncture included in the study. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Aniline Compounds |
| D000588 | Amines |