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NCT04003012 · ClinicalTrials.gov registry record · Phase 4
Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures
A Phase 4 study, sponsored by CAMC Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT04003012: Completed Phase 4 study, sponsored by CAMC Health System.
NCT04003012 is a Phase 4 study that has completed, run by CAMC Health System. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04003012, a Phase 4 study, has completed, sponsored by CAMC Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Lidocaine
- DRUG EMLA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-07-19 |
| Est. Completion | 2021-07-20 |
| Phase | Phase 4 |
What the finished NCT04003012 record still lists
NCT04003012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Lidocaine is the first listed.
NCT04003012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04003012 about?
NCT04003012 is a clinical study titled "Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures". 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 testin...
What is the current status of trial NCT04003012?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2019-07-19. Estimated completion is 2021-07-20.
What interventions are being tested in trial NCT04003012?
The interventions under investigation include: Lidocaine (DRUG), EMLA (DRUG).
Who is sponsoring clinical trial NCT04003012?
This trial is sponsored by CAMC Health System, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04003012's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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