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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 is a Phase 4 study that has completed, run by CAMC Health System. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04003012
The ClinicalTrials.gov registry entry for NCT04003012 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CAMC Health System, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lidocaine is the first listed.
NCT04003012 reports 0 study locations.
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.
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