EMLA Cream for Pain in Skin Cancer

Overseen by Carlo M. Contreras, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Narcotics

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial tests how well EMLA topical cream works in treating pain in patients with skin cancers receiving Technetium 99 injections for a lymphoscintigraphy mapping procedure. A lymphoscintigraphy mapping procedure is used to find the main or lead lymph node (tissue that fight infection) so it can be removed and checked for tumor cells. Using lymphoscintigraphy to highlight and then surgically remove lymph nodes is standard way to treat skin cancer for many patients. The Technetium 99 injections used for lymphoscintigraphy can be briefly painful due to the sensitivity of the nerve endings in the skin. The EMLA topical cream, which contains a numbing medicine to block pain from nerve endings, has been studied in breast cancer patients with a difference in pain reported, but this is the first time it has been studied in patients undergoing lymphoscintigraphy for skin cancer. This study may help researchers learn whether the use of EMLA cream may improve the associated pain at the time of the lymphoscintigraphy procedure.

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.

What data supports the effectiveness of the drug EMLA cream for pain relief in skin cancer?

EMLA cream, which contains lidocaine and prilocaine, has been shown to effectively reduce pain on both normal and diseased skin, making it useful for various medical procedures. Studies indicate that it provides effective pain relief when applied correctly, such as under an occlusive dressing for at least 45 minutes before procedures. ^{1 2 3 4 5}

Is EMLA cream safe for use in humans?

EMLA cream, which contains lidocaine and prilocaine, has been found to be safe for use on both normal and diseased skin, with blood concentrations of its active ingredients remaining below toxic levels. It has been used safely for various medical procedures, and no severe adverse reactions were reported in studies. ^{3 4 6 7 8}

How does EMLA cream differ from other skin cancer pain treatments?

EMLA cream is unique because it is a topical anesthetic containing a mixture of lidocaine and prilocaine, which penetrates the skin to provide pain relief. Unlike other treatments that may involve systemic medication or invasive procedures, EMLA is applied directly to the skin, making it a non-invasive option for managing pain in skin cancer. ^{1 3 4 8 9}

Research Team

Carlo M. Contreras, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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.

I am between 18 and 99 years old.

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.

Trial Timeline

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

Treatment Details

Interventions

• Eutectic Mixture of Local Anesthetics (Local Anesthetic)
• Questionnaire Administration (Other)

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.

Participant Groups

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+

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Interim Chief Executive Officer since 2022

MD, MBA

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Chief Medical Officer since 2018

MD

Findings from Research

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 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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

EMLA: a new topical anesthetic. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. India 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

EMLA. A new and effective topical anesthetic. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a new cutaneous topical anesthesia preparation. [2018]

6. Japan pubmed.ncbi.nlm.nih.gov

[Transdermal Local Anesthetics]. [2018]

7. Sweden pubmed.ncbi.nlm.nih.gov

Pain control in the surgical debridement of leg ulcers by the use of a topical lidocaine--prilocaine cream, EMLA. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Use of EMLA cream in the treatment of post-herpetic neuralgia. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

EMLA cream-induced irritant contact dermatitis. [2019]