Our topical anesthetic gels including TAC 20 alternate, Profound, and BTT 12.5 are popular with dentists in multiple specialties. Since these products are all compounded, they are not FDA-approved. Without clinical trials and studies that demonstrate the efficacy and safety of particular dosages, most dentists rely on their experience and the advice of their peers when using compounded products. However there are general guidelines that can be used for applying compounded topical anesthetics that can reduce the risk of adverse effects and improve effectiveness.
Why Are Compounded Products not FDA-Approved?
No products made by compounding pharmacies have FDA-approval. The rigorous process that a drug goes through to gain FDA approval is limited to manufacturers. Since each prescription is made individually by a compounding pharmacy, it would be impossible to put each of them through the FDA approval process. Compounding pharmacies are exempt from the approval process for new drugs as long as they adhere to certain strict standards of preparing prescriptions as outlined by FDA and the state boards of pharmacy. All compounded topical anesthetics are not approved by the FDA and do not have FDA indications for appropriate applications, patient selection, or dosages.
What is in Compounded Topical Anesthetic Gels?
The topical anesthetic gels we compound are much stronger than anything that is available commercially. There are many studies demonstrating the effectiveness of the individual ingredients (such as benzocaine and tetracaine) but not many that have studied a combination of multiple anesthetics. Dentists still use them on a daily basis in their practices and find them to be both effective and safe.
The dental anesthetic gels we compound include combinations of lidocaine, tetracaine, prilocaine, and phenylephrine. These anesthetics have been used for many years in dentistry and other specialties. The combination gels are faster-acting and have a longer time of duration than commercially available products. The most common formulations we compound include:
TAC 20: Lidocaine 20%, Tetracaine 4%, Phenylephrine 2%
Profound: Lidocaine 10%, Tetracaine 4%, Prilocaine 10%
BTT 12.5: Lidocaine 12.5%, Tetracaine 12.5%, Prilocaine 3%, Phenylephrine 3%
Important Considerations Before Using Compounded Topical Anesthetics
Since these anesthetic gel formulations are more powerful than commercially available products, they also have a higher chance for adverse effects. There are a few important considerations that every dental professional should take note of before using a compounded topical anesthetic.
- Hypersensitivity and cross-sensitivity to ingredients can occur. Each patient can have unique sensitivities to particular ingredients. This can be either due to individual anesthetic ingredients, to the vehicle, or to a combination of ingredients.
- Even though a larger patient can tolerate a larger anesthetic dose does not mean they need one. When the anesthetic is applied locally the dosage needed will be more consistent between patients.
- It is easy to use more gel than is needed thinking it will improve the anesthetic effects. Using a consistent amount will help reduce the chances of a reaction. The majority of adverse effects from topical anesthetic gels come from using too much gel and leaving it on too long.
- Dental anesthetic gels may cause necrosis (sloughing of tissue) if left on the oral mucosa more than 2-3 minutes. The gel should always be removed before sloughing can occur.
- The anesthetic ingredients in topical anesthetics are vasodilators. The use of a vasoconstrictor helps reduce how quickly the anesthetics are absorbed and also reduces bleeding. Phenylephrine is included as a vasoconstrictor in most of our compounded topical anesthetic gels.
- Pediatric patients, depending on their weight, may need a topical anesthetic gel that is not as strong as TAC 20 alternate, Profound, or BTT gels. We make a Profound “Lite” gel that halves the percentages of ingredients in Profound gel. Dentists frequently use this for some of their younger pediatric patients, and it includes lidocaine 5%, prilocaine 5%, and tetracaine 2%.
Possible Adverse Effects
The majority of patients who are given a topical anesthetic gel before a procedure will not experience any adverse effects. The most common adverse reaction patients experience is a headache, which is still rare when the gels are applied appropriately. With excessively high concentrations, a patient can also experience heart palpitations and excitation. Some of the possible adverse effects include:
- Sloughing of tissue if gel is left on mucosa too long.
- High plasma concentrations can induce central nervous system excitation. This is more likely to happen when phenylephrine is included but can result from anesthetics used on their own as well.
- Cardiovascular symptoms including hypertension, tachycardia, and arrhythmias.
- Allergic reaction to particular anesthetic ingredients.
- Suppression of gag reflex.
- Methemoglobinemia with prilocaine and benzocaine. Symptoms can include shortness of breath, a bluish discoloration of the skin, headache, fatigue, and dizziness.
Instructions and Tips for Applying Compounded Dental Anesthetic Gels
The actual steps to applying dental anesthetic gel are simple:
- Clean and dry the area where anesthetic gel will be applied.
- Apply dental anesthetic gel sparingly to the mucosa.
- Rinse off within 2-3 minutes to avoid sloughing of tissue.
- Full anesthesia will occur in about 5 minutes and last around 20-30 minutes.
If dental anesthetic gel will be used on the entire mouth for cleaning, anesthetize quadrants separately. Anesthetic gel should not be applied to the entire mouth at once. One of the most common methods dental professionals use to apply compounded topical anesthetic gels is with strips of gauze. The gel is applied to the gauze, and then the gauze is held on the area to be anesthetized.
An example of how to measure the amount of anesthetic needed would be to take 3g/3ccs of the anesthetic gel and divide it among 4 strips of gauze that will each fit one quadrant, which comes to about 0.75g per quadrant. This is just a general guideline, however – dentists should always use the amount they think is appropriate based on their own clinical experience. A good rule of thumb is to use the least amount of anesthetic gel needed to effectively numb the patient.
- Topical anesthesia – Journal of Anaesthesiology Clinical Pharmacology
- Comparative Efficacy of 2 Topical Anesthetics for the Placement of Orthodontic Temporary Anchorage Devices – Anesthesia Progress
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