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

NCT04003012 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-567
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post Lumbar Puncture PRN Pain Medication Usage

  24 hours following lumbar puncture

Study Arms (2)

EMLA

ACTIVE COMPARATOR

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

Lidocaine

ACTIVE COMPARATOR

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

Interventions

EMLA DRUG

EMLA cream (lidocaine 2.5% and prilocaine 2.5%)

EMLA

Lidocaine DRUG

lidocaine 1%

Lidocaine

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

CAMC - Women and Children's Hospital

Charleston, West Virginia, 25302, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Stephanie Thompson
• Organization: CAMC Institute of Academic Medicine

stethompson@camc.org

304-388-9911

Study Officials

• Mohamad Badawi, MD

  WVU-Charleston and CAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor WVU-Charleston

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: July 19, 2019
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: March 9, 2023
• Results First Posted: March 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)