Phase 4
Completed N=10
Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures
Source: ClinicalTrials.gov NCT04003012 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale — 0; 0; 0; 0 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale |
0; 0; 0; 0 | — |
| SECONDARY Post Lumbar Puncture PRN Pain Medication Usage |
1; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04003012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.