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

NCT ID: NCT04003012

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-19
• Study Completion Date: 2021-07-20

Brief 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.

Conditions

Leukemia-Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

EMLA

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.

Group Type: ACTIVE_COMPARATOR

EMLA

Intervention Type: DRUG

EMLA cream (lidocaine 2.5% and prilocaine 2.5%)

Lidocaine

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

lidocaine 1%

Interventions

EMLA

EMLA cream (lidocaine 2.5% and prilocaine 2.5%)

Intervention Type: DRUG

Lidocaine

lidocaine 1%

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CAMC Health System

OTHER

Sponsor Role: lead

Responsible Party

Mohamad Badawi, MD

Assistant Professor WVU-Charleston

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamad Badawi, MD

Role: PRINCIPAL_INVESTIGATOR

WVU-Charleston and CAMC

Locations

CAMC - Women and Children's Hospital

Charleston, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-567

Identifier Type: -

Identifier Source: org_study_id