Leukemia-LymphomaPhase 4NCT04003012
Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures
A Phase 4 study testing EMLA and Lidocaine in people with Leukemia-Lymphoma, run by CAMC Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Leukemia-Lymphoma
- What is being tested?
- EMLA and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2019to 20 Jul 2021
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
CAMC - Women and Children's Hospital
Charleston, West Virginia, 25302
About this study
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.
- Conditions
- Leukemia-Lymphoma
- Being tested
- EMLA, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLADrug
EMLA cream (lidocaine 2.5% and prilocaine 2.5%)
LidocaineDrug
lidocaine 1%
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: EMLA |
| 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Lumbar Puncture Pain Score at 30-60 Minutes
Wong-Baker Faces Pain Rating Scale assessed 30-60 minutes following lumbar puncture. Wong-Baker Faces Pain Rating 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.
Measured: 30-60 minutes after lumbar puncture
Post Lumbar Puncture Pain Score at 24 Hours
Wong-Baker Faces Pain Rating Scale assessed 30-60 minutes following lumbar puncture. Wong-Baker Faces Pain Rating 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.
Measured: 24 hours after lumbar puncture
Secondary outcomes (1)
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.
Measured: 24 hours following lumbar puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start19 Jul 2019
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Leukemia-LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Thompson, CAMC Health System
- Investigators
- Mohamad Badawi, MD, Principal investigator, WVU-Charleston and CAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003012
- Sponsor's protocol ID
- 19-567
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2019
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No