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EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers

NCT06223659 · Ohio State University Comprehensive Cancer Center
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Official title
Investigating the Use of EMLA Topical Cream for Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Cutaneous Cancers
About this study
PRIMARY OBJECTIVE: 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.
Eligibility criteria
Inclusion Criteria: * Biologic males or females * 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: * Known allergy or intolerance to EMLA cream, lidocaine, prilocaine, or any other local anesthetic * 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
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-12-19
Estimated completion: 2026-10-31
Last updated: 2026-03-10
Interventions
Drug: Eutectic Mixture of Local AnestheticsDrug: Placebo AdministrationOther: Questionnaire Administration
Primary outcomes
  • Pain score (Up to 1 year)
Sponsor
Ohio State University Comprehensive Cancer Center · other
Contacts & investigators
ContactThe Ohio State University Comprehensive Cancer Center · contact · OSUCCCClinicaltrials@osumc.edu · 800-293-5066
InvestigatorCarlo M Contreras, MD · principal_investigator, Ohio State University Comprehensive Cancer Center
All locations (1)
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
EMLA Topical Cream for Treatment of Pain in Patients Receiving Intra-Dermal Technetium 99 Injections for Lymphoscintigraphy for Skin Cancers · TrialPath