EMLA Cream for Pain in Skin Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Narcotics

Disqualifiers: Allergy to EMLA, Pregnancy, Chronic pain, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of EMLA cream, a numbing agent, in easing pain for individuals with skin cancer undergoing a lymphoscintigraphy procedure. This procedure involves a potentially painful injection of Technetium 99 to map lymph nodes for cancer treatment. Participants will receive either EMLA cream or a placebo cream before the injection to determine if EMLA reduces pain. Eligible participants have a confirmed skin cancer type, such as melanoma or squamous cell carcinoma, and are scheduled for a lymphoscintigraphy procedure. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you require narcotics within the 7 days before the procedure, you may not be eligible to participate.

Is there any evidence suggesting that EMLA cream is likely to be safe for humans?

Research has shown that EMLA cream, which contains the numbing agents lidocaine and prilocaine, is generally safe for skin application. Studies indicate that it can reduce pain during various medical procedures.

However, rare side effects have been reported. For example, one study described a 71-year-old man who developed methemoglobinemia after using EMLA cream on a leg ulcer. Methemoglobinemia is a blood disorder that affects oxygen delivery in the body. This reaction is very rare and usually occurs with high doses or prolonged use of the cream.

Most people do not experience serious side effects. If any occur, they are usually mild, such as skin redness or irritation. EMLA cream has been used in various situations, including with children, without significant adverse effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin cancer?

Researchers are excited about using EMLA Cream for pain in skin cancer because it offers a non-invasive way to alleviate discomfort. Unlike standard oral pain medications, which can take time to work and may have systemic side effects, EMLA Cream is applied directly to the skin, providing rapid and localized pain relief. This localized approach minimizes the potential for systemic side effects, making it a promising option for patients undergoing procedures like Tc99 lymphoscintigraphy. Additionally, the cream combines two local anesthetics, lidocaine and prilocaine, enhancing its effectiveness in numbing the skin compared to existing single-agent topical anesthetics.

What evidence suggests that EMLA cream might be an effective treatment for pain in skin cancer patients undergoing lymphoscintigraphy?

Research has shown that EMLA cream, a mix of lidocaine and prilocaine, helps reduce pain. In studies with children undergoing cancer treatment, EMLA cream led to less movement and reduced the need for extra medication during procedures. Other research indicates that EMLA cream is favored for minor outpatient procedures because it numbs effectively. Patients have reported feeling less pain during needle procedures compared to other pain relief methods. In this trial, participants in one arm will apply EMLA cream topically to the skin 30 minutes before the Tc99 lymphoscintigraphy procedure. These findings suggest that EMLA cream can effectively reduce pain during medical procedures like lymphoscintigraphy. ^{2 3 4 6 7}

Who Is on the Research Team?

Carlo M. Contreras, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with skin cancers like Squamous Cell Carcinoma and Merkel Cell Carcinoma, who are undergoing a lymphoscintigraphy mapping procedure using Technetium 99 injections. The study aims to include those who need their lead lymph node identified and possibly removed.

Inclusion Criteria

I have a skin cancer diagnosis that requires a special lymph node biopsy.

Exclusion Criteria

Pregnancy

Participant self-declared or Ohio State University (OSU) medical chart listing chronic pain as a pre-existing diagnosis

I cannot have a Tc99 injection for lymph node mapping due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply EMLA or placebo cream 30 minutes prior to Tc99 lymphoscintigraphy procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain and adverse events after the procedure

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Eutectic Mixture of Local Anesthetics
• Questionnaire Administration

Trial Overview The trial is testing EMLA topical cream, which contains numbing medicine, against a placebo to see if it reduces pain from the injections during the lymphoscintigraphy procedure in skin cancer patients.

How Is the Trial Designed?

Group I: Cohort 1 (EMLA cream) Experimental Treatment 2 Interventions

Patients apply EMLA cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

Group II: Cohort 2 (placebo cream) Placebo Group 2 Interventions

Patients apply placebo cream topically to skin 30 minutes prior to Tc99 lymphoscintigraphy procedure.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

In a study involving 99 pediatric patients, 10% lidocaine spray provided effective pain relief for intravenous cannulation, showing similar pain scores to EMLA cream but with a faster onset of action.

Both the lidocaine spray and EMLA cream resulted in successful cannulations on the first attempt without any adverse effects, indicating their safety and efficacy for use in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of 10% lidocaine spray versus eutectic mixture of 2.5% lidocaine and 2.5% prilocaine (EMLA) to attenuate pain of peripheral venous cannulation in children: A prospective randomized control trial at a tertiary care centre. Kulkarni, MM., Patil, AT., Sinha, S.[2023]

EMLA, a topical anesthetic made of lidocaine and prilocaine, is effective in reducing pain during the placement of large IV catheters when applied for at least 45 minutes under an occlusive bandage.

In a double-blind study, patients reported significantly less pain at the EMLA application site compared to placebo, confirming its efficacy in providing cutaneous anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new cutaneous topical anesthesia preparation. Maddi, R., Horrow, JC., Mark, JB., et al.[2018]

EMLA cream, a combination of lidocaine and propitocaine, is effective for topical anesthesia with high skin penetrability and confirmed safety, as blood levels of its active ingredients remain below toxic levels.

The use of EMLA cream is expanding in Japan for pain reduction not only in skin laser therapy but also for reducing pain from needle punctures, indicating its versatility in various medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transdermal Local Anesthetics]. Hanaoka, K., Arita, H., Nagase, M., et al.[2018]

A case of irritant contact dermatitis was reported in a 6-year-old boy with Wiskott-Aldrich syndrome after using EMLA cream, highlighting a rare side effect of this commonly used topical anesthetic.

Histopathological analysis revealed significant skin damage, including necrosis of skin cells and inflammation, suggesting that while EMLA is generally safe, it can cause serious skin reactions in sensitive individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMLA cream-induced irritant contact dermatitis. Dong, H., Kerl, H., Cerroni, L.[2019]

In a study of 76 adult volunteers, applying EMLA cream for 20 minutes with heat resulted in significantly better pain relief during intravenous catheterization compared to placebo, demonstrating the effectiveness of heat in enhancing analgesia.

However, the traditional method of applying EMLA cream for 60 minutes without heat still provided superior pain relief compared to the 20-minute application with heat, indicating that while heat can improve efficacy, longer application times are more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does using heat with eutectic mixture of local anesthetic cream shorten analgesic onset time? A randomized, placebo-controlled trial. Liu, DR., Kirchner, HL., Petrack, EM.[2018]

EMLA cream, which contains 5% lidocaine and prilocaine, provides effective pain relief for both normal and diseased skin, making it suitable for superficial surgeries and other clinical procedures.

For optimal effectiveness, EMLA must be applied in sufficient quantity and covered to enhance absorption, and it should be used at the appropriate time before the medical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMLA: a new topical anesthetic. Juhlin, L., Evers, H.[2018]

In a study involving 80 patients with leg ulcers, EMLA 5% cream significantly reduced pain during surgical cleansing compared to a placebo, with median pain scores of 18.5 mm for EMLA versus 84 mm for placebo (p < 0.01).

The study found no severe adverse reactions to EMLA cream, indicating it is a safe and effective option for pain management in the surgical debridement of leg ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain control in the surgical debridement of leg ulcers by the use of a topical lidocaine--prilocaine cream, EMLA. Holm, J., Andrén, B., Grafford, K.[2018]

EMLA cream, a combination of lidocaine and prilocaine, effectively treated post-herpetic neuralgia that was resistant to other therapies, demonstrating its potential as a viable option for pain management.

The cream works by penetrating the skin into the dermis after being applied for 1 to 2 hours, allowing for localized anesthesia and relief from nerve pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of EMLA cream in the treatment of post-herpetic neuralgia. Litman, SJ., Vitkun, SA., Poppers, PJ.[2019]

EMLA, a mixture of 2.5% lidocaine and 2.5% prilocaine, provides effective and safe pain relief for various medical procedures, including superficial surgeries and venipuncture, when applied for at least 1 hour under an occlusive dressing.

Since its approval in Canada in 1991, EMLA has been used not only for standard procedures but also for conditions like postherpetic neuralgia and hyperhidrosis, demonstrating its versatility in treating both normal and diseased skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMLA. A new and effective topical anesthetic. Lycka, BA.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8528901/

Eutectic mixture of lidocaine and prilocaine decreases ... EMLA cream results in less movement and less propofol administration in pediatric oncology patients undergoing sedation for LP.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022347611800053

Eutectic mixture of local anesthetics (EMLA): What is it? ... Study objective: To compare the anesthetic efficacy of EMLA (eutectic mixture of local anesthetics) cream with that of TAC (tetracaine, adrenaline, and ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pbc.27957

Eutectic mixture of lidocaine and prilocaine versus 1% ... LPs in the EMLA group were completed in a shorter time (7.5 minutes [CI 7.0–8.1] vs 9.4 minutes [CI 8.9–9.9]) with a faster recovery time (38.7 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10388875/

Efficacy of a eutectic mixture of local anesthetics as ... We report our experience with EMLA cream in 17 adult and 24 pediatric patients. We find EMLA to be the preferred anesthetic for performing minor outpatient ...

5. researchgate.net researchgate.net/publication/328159486_The_eutectic_mixture_local_anesthetics_EMLA_cream_is_more_effective_on_venipuncture_pain_compared_with_lidocaine_tape_in_the_same_patients

(PDF) The eutectic mixture local anesthetics (EMLA) cream ... Our results strongly suggest that EMLA cream is more effective for venipuncture pain relief than lidocaine tape.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11052939/

Acute Systemic Toxicity Caused by Topical Application of ... We report the case of a 71-year-old man who developed methemoglobinemia and systemic intoxication upon topical application of EMLA cream for leg ulcer and ...

7. researchgate.net researchgate.net/publication/265692220_Risk_of_Systemic_Toxicity_With_Topical_LidocainePrilocaine_A_Review

Risk of Systemic Toxicity With Topical Lidocaine/Prilocaine ... To date, systemic toxicity has been reported in humans receiving high concentrations (10% lidocaine) of topical local anesthetics over a ...