Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures

CAMC Health System

Status and phase: Completed; Phase 4

Conditions: Leukemia-Lymphoma

Treatments: Drug: Lidocaine; Drug: EMLA

Study type: Interventional

Funder types: Other

Identifiers

NCT04003012

19-567

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

EMLA

Active Comparator group

Description:

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.

Treatment:

Drug: EMLA

Lidocaine

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine