Vibração versus lidocaína 7% com tetracaína 7% para redução da dor local durante injeção cosmética de toxina botulínica no terço superior da face de mulheres: ensaio clínico randomizado, duplo-cego e autocontrolado

Abstract

Pain in multiple punctures for the administration of Botulinum Toxin type A (TxB-A) in the face is a persistent challenge, as infiltrative anesthesia is not viable. Strategies such as topical anesthetic creams have been explored, but adverse effects, high cost and longer clinical time make them less attractive. The application of vibratory stimuli during the procedure appears as a faster and more economical alternative, although with less scientific basis. The objective of the study was to evaluate the level of pain, satisfaction and patient preference for different anesthetic techniques during the cosmetic application of TxB-A in the upper third of the face, through a Randomized Clinical Trial. Patients were randomized into 3 groups with a split-face design and receiving exactly the same amount of toxin (IU), with the patient being their own control group. The groups were: (G1) vibratory anesthesia x placebo, (G2) topical anesthesia x placebo, and (G3) vibratory anesthesia x topical anesthesia. The placebo had the same color and consistency as the anesthetic ointment. The side receiving the interventions was also randomized. Immediately after the procedure, a questionnaire was administered, consisting of questions and a visual analogue scale (VAS) to measure pain. In the results, statistically significant differences were found on the VAS scale for pain when comparing the three groups: G1 (vibration 5.02 ±2.56 versus placebo 6.00 ±2.75; P = 0.034); G2 (topical anesthetic 4.69 ±2.45 versus placebo 5.50 ±2.38; (P = 0.039); G3 topical anesthetic 4.89 ±2.29 versus vibration 6.06 ±2.22; P = 0.048). Regarding satisfaction with the technique, there were no statistically significant differences between vibration, placebo, or topical (G1: P = 0.729; G2: P = 0.252; G3: P = 0.532), but vibration and topical prevailed more than placebo (P = 0.398). Regarding the recommendation and reuse of the technique, only G3 showed differences in response frequencies (P = 0.010), with the highest recommendation being on the side applied with topical anesthetic. When analyzing each group, we found that the discomfort was alleviated: G1 (vibration in 75% of cases), G2 (topical anesthetic in 71.9% of cases) and G3 (topical anesthetic in 55.6% of cases). Topical anesthetic was the most effective technique recommended by patients. However, the vibratory stimulus was also effective in reducing pain in 75% of cases of unilateral vibration, 44.4% vibration versus placebo, and in the total sample it was one of those that received the greatest satisfaction chosen.