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 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.

Study Overview

• Status: Completed
• Conditions: Leukemia-Lymphoma
• Intervention / Treatment: Drug: EMLA; Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohamad Badawi, MD; Phone Number: 304-388-1552; Email: mobadawi@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25302
      • CAMC - Women and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: EMLA; EMLA cream (lidocaine 2.5% and prilocaine 2.5%)
Active Comparator: 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.	Drug: Lidocaine; lidocaine 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale	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 each arm's 10 patients. Reported values were identical between arms.	, pain will be assessed at 30 - 60 minutes after waking up after lumbar puncture and 24 hours after lumbar puncture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Lumbar Puncture PRN Pain Medication Usage	Use of PRN or "as needed" pain medicine by the patient was determined. Patients with parent/guardian assistance were asked to record the "as needed" pain control medication, acetaminophen. the patient used within the 24 hours after lumber puncture. Counts of patients using acetaminophen in the 24 hours following lumber puncture are reported.	24 hours following lumbar puncture

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Mohamad Badawi, MD, WVU-Charleston and CAMC

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 19-567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes