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

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ClinicalTrials.gov Identifier: NCT04003012
Recruitment Status : Completed
First Posted : July 1, 2019
Results First Posted : March 9, 2023
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamad Badawi, MD, CAMC Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Leukemia-Lymphoma Drug: EMLA Drug: Lidocaine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures
Actual Study Start Date : July 19, 2019
Actual Primary Completion Date : July 20, 2021
Actual Study Completion Date : July 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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%


Outcome Measures
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Primary Outcome Measures :
  1. Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale [ Time Frame: , pain will be assessed at 30 - 60 minutes after waking up after lumbar puncture and 24 hours after lumbar puncture ]

    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.



Secondary Outcome Measures :
  1. Post Lumbar Puncture PRN Pain Medication Usage [ Time Frame: 24 hours following lumbar puncture ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003012


Locations
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United States, West Virginia
CAMC - Women and Children's Hospital
Charleston, West Virginia, United States, 25302
Sponsors and Collaborators
CAMC Health System
Investigators
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Principal Investigator: Mohamad Badawi, MD WVU-Charleston and CAMC
  Study Documents (Full-Text)

Documents provided by Mohamad Badawi, MD, CAMC Health System:
Study Protocol and Statistical Analysis Plan  [PDF] August 30, 2019

More Information
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Responsible Party: Mohamad Badawi, MD, Assistant Professor WVU-Charleston, CAMC Health System
ClinicalTrials.gov Identifier: NCT04003012    
Other Study ID Numbers: 19-567
First Posted: July 1, 2019    Key Record Dates
Results First Posted: March 9, 2023
Last Update Posted: March 9, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action