Leukemia-Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGEMLA
EMLA cream (lidocaine 2.5% and prilocaine 2.5%)
DRUGLidocaine
lidocaine 1%
Sponsors
CAMC Health System
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric cancer patients (aged 3-18) with a diagnosis of leukemia or lymphoma * Patients are expected to receive serial (i.e. \> 1) LP as outpatients in Charleston Area Medical Center Children's Cancer Center in the course of 12 months for diagnostic and/or treatment purposes
Exclusion criteria
* Patients not in the age range * Non-cancer patients * Allergy to amide anesthetics * Patients treated with class I and III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide) * Patients with congenital or idiopathic methemoglobinemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale | , pain will be assessed at 30 - 60 minutes after waking up after lumbar puncture and 24 hours after lumbar puncture | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Lumbar Puncture PRN Pain Medication Usage | 24 hours following lumbar puncture | 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. |
Countries
United States
Participant flow
Recruitment details
10 patients were screen and enrolled in the study
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | EMLA for First Lumbar Puncture, Lidocaine Injection for Second Lumbar Puncture | Total | Lidocaine Injection for First Lumbar Puncture, EMLA for Second Lumbar Puncture |
|---|---|---|---|
| Age, Continuous | 5 years | 5.5 years | 6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment United States | 5 participants | 10 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: , pain will be assessed at 30 - 60 minutes after waking up after lumbar puncture and 24 hours after lumbar puncture
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EMLA | Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale | Wong-Baker Faces Pain Rating Scale Score 30 - 60 minutes after waking up after lumbar puncture | 0 score on a scale |
| EMLA | Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale | Wong-Baker Faces Pain Rating Scale Score 24 hours after lumbar puncture | 0 score on a scale |
| Lidocaine Injection | Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale | Wong-Baker Faces Pain Rating Scale Score 30 - 60 minutes after waking up after lumbar puncture | 0 score on a scale |
| Lidocaine Injection | Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale | Wong-Baker Faces Pain Rating Scale Score 24 hours after lumbar puncture | 0 score on a scale |
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.
Time frame: 24 hours following lumbar puncture
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EMLA | Post Lumbar Puncture PRN Pain Medication Usage | 1 Participants |
| Lidocaine Injection | Post Lumbar Puncture PRN Pain Medication Usage | 2 Participants |