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

Leukemia-Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003012
• Other study ID #: 19-567
• Status: Completed
• Phase: Phase 4
• Start date: July 19, 2019
• Est. completion date: July 20, 2021

Study information

• Verified date: February 2023
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia-Lymphoma

Intervention

Drug:
• EMLA
EMLA cream (lidocaine 2.5% and prilocaine 2.5%)
• Lidocaine
lidocaine 1%

Locations

Country	Name	City	State
United States	CAMC - Women and Children's Hospital	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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