EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers
NCT ID: NCT06223659
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2023-12-19
2025-12-31
Brief Summary
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Detailed Description
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I. Evaluate if the application of eutectic mixture of local anesthetics (EMLA) topical cream (2.5% lidocaine mixed with 2.5% prilocaine) prior to intra-dermal Technetium 99 sulfur colloid (Tc99 injection) for lymphoscintigraphy can improve associated pain.
OUTLINE: Patients are randomized to 1 of 2 cohorts.
COHORT 1: Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.
COHORT 2: Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cohort 2 (placebo cream)
Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.
Placebo Administration
Apply topically to skin
Questionnaire Administration
Ancillary studies
Cohort 1 (EMLA cream)
Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.
Eutectic Mixture of Local Anesthetics
Apply topically to skin
Questionnaire Administration
Ancillary studies
Interventions
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Eutectic Mixture of Local Anesthetics
Apply topically to skin
Placebo Administration
Apply topically to skin
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 - 99 years of age
* Histologically confirmed cutaneous melanoma, Merkel cell carcinoma, squamous cell carcinoma, or other cutaneous malignancy for which lymphoscintigraphy and sentinel lymph node biopsy has been recommended.
Exclusion Criteria
* History of adhesive allergy
* Contraindication to Tc99 injection for sentinel lymph node mapping
* Incarcerated patients
* Patients incapable of independently providing consent
* Mucosal or genital lymphoscintigraphy site
* Pregnancy
* Participant self-declared or Ohio State University (OSU) medical chart listing chronic pain as a pre-existing diagnosis
* Participants with chronic pain as defined by the Centers for Disease Control and Prevention (CDC):"pain lasting 3 months or more that can be caused by a disease or condition, injury, medical treatment, or unknown reason" excluding those with stable co-morbid conditions such as peripheral neuropathy, fibromyalgia, arthritis, and cancer-related pain who do not require narcotics. Patients who require narcotics at any time within the 7-day period leading up to the procedure
18 Years
99 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Carlo Contreras
Principal Investigator
Principal Investigators
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Carlo M Contreras, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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The Jamesline
Other Identifiers
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NCI-2023-10465
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-23046
Identifier Type: -
Identifier Source: org_study_id
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