BLT vs Lidocaine for Procedural Pain
Recruiting in 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
Must not be taking: Anxiolytics, Opiates
Disqualifiers: Cardiac/respiratory disease, Seizure disorder, Neuropathies, others
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking anxiolytics (medications for anxiety) or opiates (pain medications) as they may interfere with the study results.
What data supports the effectiveness of the drug BLT (Benzocaine/Lidocaine/Tetracaine) for procedural pain?
Research shows that a cream containing lidocaine and tetracaine is effective in reducing pain during dermatologic procedures, such as laser treatments, and is associated with mild side effects. This suggests that the combination of these anesthetics in BLT could also be effective for procedural pain.
12345Is the combination of lidocaine, benzocaine, and tetracaine safe for use in humans?
Research shows that lidocaine and tetracaine creams are generally safe for use in humans, with mild side effects. Studies on lidocaine creams, like LMX4, found no significant toxicity even when used in moderate amounts for cosmetic procedures.
12367What makes the BLT drug unique for procedural pain?
The BLT drug, which combines benzocaine, lidocaine, and tetracaine, is unique because it offers a combination of three anesthetics that can provide effective pain relief with a shorter application time compared to some other topical anesthetics. This makes it particularly useful for quick procedures, as it can reduce waiting time for pain relief to take effect.
12348Eligibility 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.
I regularly see a dermatologist for skin treatments like IPL, PDL, or microneedling.
Exclusion Criteria
I am currently taking anxiety medication or painkillers.
I am currently pregnant or breastfeeding.
I am being treated for a skin condition that could affect this study's evaluation.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive topical anesthetics (BLT and Lidocaine) applied to the face prior to IPL, PDL, and microneedling procedures
1 day
1 visit (in-person)
Follow-up
Participants are monitored for pain relief effectiveness immediately after treatment
1 day
Participant Groups
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
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.
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.
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.
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.
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.
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).
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.
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.