BLT vs Lidocaine for Procedural Pain
Palo Alto (17 mi)Overseen byBrian J Simmons, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Dartmouth-Hitchcock Medical Center
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.
Is the drug BLT (Benzocaine/Lidocaine/Tetracaine) a promising option for reducing pain during procedures?Yes, BLT is a promising option for reducing pain during procedures. It is effective, easy to use, and works quickly, making it a good choice for managing pain in various medical and cosmetic procedures.14568
What safety data exists for BLT and lidocaine treatments for procedural pain?The safety data for BLT and lidocaine treatments indicate that these topical anesthetics are generally safe and effective for managing procedural pain. Lidocaine and tetracaine creams, such as Pliaglis, have been evaluated in numerous clinical trials and are associated with mild side effects. Studies have shown that lidocaine/tetracaine combinations are effective for pain relief in dermatologic procedures with a favorable safety profile. Additionally, a study on 4% liposomal lidocaine cream (LMX4) found no significant systemic toxicity or adverse effects, even with moderate amounts used in cosmetic procedures.23456
What data supports the idea that BLT vs Lidocaine for Procedural Pain is an effective treatment?The available research shows that a combination of lidocaine and tetracaine, which is part of the BLT treatment, is effective in reducing pain during dermatologic procedures. For example, one study found that this combination cream was more effective in reducing pain compared to another common anesthetic cream during radiofrequency ablation procedures. Another study highlighted that lidocaine and tetracaine cream is safe and effective for laser dermatologic procedures, offering ease of use and mild side effects. These findings suggest that BLT is a good option for managing procedural pain.14567
Do I have to stop taking my current medications for the trial?The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anxiolytics or opiates.
Eligibility Criteria
This trial is for individuals experiencing pain during specific skin procedures like IPL (intense pulsed light), PDL (pulsed dye laser), and microneedling. Details on who can join or reasons for exclusion are not provided.Inclusion Criteria
I am between 18 and 75 years old.
Exclusion Criteria
I am currently pregnant or breastfeeding.
I have a heart, lung condition, seizures, or nerve problems.
Treatment Details
The study aims to compare the effectiveness of a compounded anesthetic cream called BLT (Benzocaine/Lidocaine/Tetracaine) with a standard 4% Lidocaine cream in reducing pain from certain dermatological procedures.
2Treatment groups
Experimental Treatment
Group I: Left Side LidocaineExperimental Treatment2 Interventions
Subjects will receive topical 4% Lidocaine applied to the left side of the face and 4% BLT applied to the right side of the face prior to treatment.
Group II: Left Side BLTExperimental Treatment2 Interventions
Subjects will receive topical BLT applied to the left side of the face and 4% Lidocaine applied to the right side of the face prior to treatment.
BLT is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as BLT for:
- Pain relief during IPL, PDL, and microneedling procedures
- Minor burns and skin irritations
- Minor cuts and scrapes
- Itching
🇨🇦 Approved in Canada as BLT for:
- Pain relief during IPL, PDL, and microneedling procedures
- Minor burns and skin irritations
- Minor cuts and scrapes
- Itching
Find a clinic near you
Research locations nearbySelect from list below to view details:
Dartmouth Hitchcock Dermatology ClinicLebanon, NH
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Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
References
Tetracaine versus lidocaine-prilocaine for preventing venipuncture-induced pain in children. [2019]The efficacy of tetracaine cream versus that of lidocaine-prilocaine cream for the prevention of pain in children undergoing venipuncture was studied. Hospital inpatients 1-15 years of age received, on the back of each hand, a 30-minute application of tetracaine 4% cream or a 60-minute application of lidocaine-prilocaine cream (EMLA, Astra) before undergoing scheduled venipuncture. The phlebotomists in this open, randomized trial evaluated the efficacy of the cream at the moment of venipuncture as adequate, inadequate, or inconclusive. Blood samples were taken immediately after venipuncture from 10 patients one to five years of age to measure the serum concentrations of tetracaine and its metabolite, N-butyl-p-aminobenzoic acid. Lidocaine-prilocaine cream was significantly more efficacious in preventing pain than tetracaine 4% cream (97% of the former group [n = 32] had adequate pain relief, compared with 76% of the latter [n = 34]. The only adverse effects observed were mild local erythema in the tetracaine group and local skin blanching in the lidocaine-prilocaine group. No tetracaine could be detected in serum, and the serum concentrations of N-butyl-p-aminobenzoic acid ranged from 0 to 1.8 mg/l. Statistically, lidocaine-prilocaine cream was more efficacious than tetracaine 4% cream, but the difference is of minor clinical significance and is outweighed by the practical advantages of tetracaine 4% cream, namely the shorter application time, vasodilation and lower cost.
Safety of occluded 4% liposomal lidocaine cream. [2013]The use of topical anesthesia for pain control for dermatologic procedures is widespread. In addition to clinical procedures, such as skin biopsies, lesion removal, and electrocautery, topical anesthesia is used for pain control in a variety of cutaneous cosmetic procedures including laser procedures and injection of filler substances and/or botulism toxin. While the use of topical anesthesia is generally regarded as safe and effective, recent concern about lidocaine toxicity from the use of compounded mixtures of lidocaine for cosmetic procedures has been reported. This study evaluated the potential absorption and clinical toxicity of either 30 or 60 grams of occluded topical liposomal lidocaine (LMX4) in 8 healthy volunteers. Blood was drawn to evaluate levels of lidocaine and monoethylglycinexylidide (MEGX) metabolites prior to application of the occluded cream at 1 hour, 2 hours, 6 hours, and 24 hours post-application. Additionally, the volunteers were assessed for any clinical signs of lidocaine toxicity. All blood samples showed less than 0.5 mcg/mL of serum lidocaine and MEGX metabolite. Patients reported no systemic effects and did not show any clinical signs of lidocaine toxicity. Conclusions were that moderate amounts (30 and 60 grams-amounts used in a variety of cosmetic procedures) of occluded 4% lidocaine cream were safe; the test subjects showed no evidence of clinical toxicity and blood levels showed no evidence of significant lidocaine or lidocaine metabolites.
The use of compound topical anesthetics: a review. [2019]The author reviewed the history of, federal regulations regarding, risks of and adverse drug reactions of five compound topical anesthetics: tetracaine, adrenaline/epinephrine and cocaine (TAC); lidocaine, adrenaline/epinephrine and tetracaine (LET); lidocaine, tetracaine and phenylephrine (TAC 20 percent Alternate); lidocaine, prilocaine and tetracaine (Profound); and lidocaine, prilocaine, tetracaine and phenylephrine with thickeners (Profound PET).
Pain management with a topical lidocaine and tetracaine 7%/7% cream with laser dermatologic procedures. [2013]Pain is a common patient complaint with dermatologic laser procedures and effective pain management is important for the comfort and satisfaction of patients undergoing these procedures. Many topical anaesthetics are available as options to decrease the pain associated with these procedures, although not all have the same degree of safety. An FDA-approved lidocaine and tetracaine topical anesthetic cream [Pliaglis®, liodocaine and tetracaine 7%/7% cream (LT cream), Galderma Laboratories LP, Fort Worth, TX] is safe and effective when used with common laser therapies such as ablative and nonablative laser resurfacing, laser hair removal, laser treatment of vascular lesions, and laser tattoo removal. LT cream should be considered by dermatologists when choosing a topical anesthetic for laser dermatologic procedures.
Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. [2021]Introduction. Topical application of local anesthetics is currently considered to be the easiest, most effective, and convenient way for treatment of patients who may be undergoing superficial dermatosurgical procedures. Materials and Methods. This study compares the anesthetic potential of 2.5% lidocaine and 2.5% prilocaine topical cream with 7% lignocaine and 7% tetracaine combination cream for radio ablative dermatosurgery when applied, under occlusion, for 30 minutes. 40 subjects of achrocordons were enrolled in this split-side randomized trial. Result. The pain severity experienced by subjects in terms of visual analogue scale score was significantly lesser for lignocaine/tetracaine combination cream as compared to lidocaine/prilocaine combination. Conclusion. This small study proves the efficacy of lidocaine/tetracaine combination as a topical anesthetic cream when applied for a short time interval of 30 minutes. This will help a dermatosurgeon to perform various dermatological procedures in a better and efficient manner with a shorter waiting period for analgesia to set in.
Review of lidocaine/tetracaine cream as a topical anesthetic for dermatologic laser procedures. [2021]There are multiple different topical anesthetic options available to minimize the pain associated with cosmetic dermatologic procedures. These options, either alone or in combination, have diverse profiles for effectiveness, ease of use, application time, need for occlusion, and side effects. The lidocaine/tetracaine cream (Pliaglis(®), Galderma Laboratories, Texas, USA), one of the newer combination options, offers effective pain alleviation that has been evaluated in numerous clinical trials. This combination anesthetic is associated with a very favorable profile because of its ease of use and mild side effects compared to other topical local anesthetics. An overview of available topical local anesthetics will be provided with an outline of clinical study characteristics and results regarding the use of lidocaine/tetracaine cream.
Efficacy of lidocaine 7 %, tetracaine 7 % self-occlusive cream in reducing MAL-cPDT-associated pain in subjects with actinic keratosis: A randomized, single-blind, vehicle-controlled trial (The "3P-Trial"). [2021]Conventional photodynamic therapy (cPDT) is considered a very effective treatment of actinic keratosis (AK) lesions. However, its use is limited by the fact that this procedure could be very painful. The use of topical anesthetics such as tetracaine or lignocaine/prilocaine has shown disappointing results in term of pain reduction. A self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream (LT-C) approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures is available. There are no data regarding its pain reducing effect during cPDT. We perform a prospective, randomized, single-blind, two-center trial (The 3P-Trial) to assess the pain reduction effect of LT-C versus vehicle in subjects with AK undergoing cPDT.
Comparative Evaluation of Two Different Topical Anesthetic Agents in Controlling Pain during Intraoral Local Anesthetic Administration in Children: A Split-mouth Triple-blinded Randomized Clinical Trial. [2022]To compare the efficacy of lignocaine and benzocaine when applied as a topical anesthetic before intraoral local anesthetic administration in children.