Randomized study comparing onabotulinum toxin diluted in lidocaine and epinephrine versus saline solution for the treatment of periocular lines

Effects of lidocaine incorporation (without epinephrine) on pain and 2-week complications of botulinum toxin: a double-blind randomized placebo-controlled clinical trial

“…Although this difference did not reach the significance level ( P = 0.180), there might be a chance to see a statistically significant result if a larger number of patients had been enrolled. They also did not show any statistically significant differences in the frequency of muscle paralysis (although there seemed to be a notable difference in the first 48 h) and facial symmetry in the application of botulinum toxin diluted merely with saline solution compared to that diluted with lidocaine and epinephrine diluted 25 . Gassner and Sherris 18 assessed the effects of the incorporation of lidocaine plus epinephrine into botulinum toxin on the predictability of botulinum injection in 10 patients 18 .…”

“…There is no similar study that assesses the findings of the current study. There are however, two clinical series and two controversial clinical trial studies on the effect of dilution of botulinum toxin with lidocaine plus epinephrine 3 , 18 , 25 , 26 : a clinical trial of 10 patients only on complications but not pain, a clinical trial of 15 patients only on pain incidence, and two clinical series without any control groups. The clinical trials were as small as 10 and 15 participants 18 , 25 , and only one had examined pain 25 .…”

“…There are however, two clinical series and two controversial clinical trial studies on the effect of dilution of botulinum toxin with lidocaine plus epinephrine 3 , 18 , 25 , 26 : a clinical trial of 10 patients only on complications but not pain, a clinical trial of 15 patients only on pain incidence, and two clinical series without any control groups. The clinical trials were as small as 10 and 15 participants 18 , 25 , and only one had examined pain 25 . One of them suggested that the incorporation of lidocaine and epinephrine does not make the injection outcomes more predictable, nor would it reduce the incidence of pain 25 ; they did not assess the intensity of pain 25 .…”

“…The clinical trials were as small as 10 and 15 participants 18 , 25 , and only one had examined pain 25 . One of them suggested that the incorporation of lidocaine and epinephrine does not make the injection outcomes more predictable, nor would it reduce the incidence of pain 25 ; they did not assess the intensity of pain 25 . The other reported that the addition of lidocaine and epinephrine would make the toxin’s effect appear immediately and therefore increase predictability; they did not assess pain 18 .…”

“…Kim et al 3 conducted another case series study and concluded that diluting botulinum toxin with lidocaine and epinephrine might improve patient satisfaction with injections for facial rejuvenation, due to faster results, longer effects, less bruising and pain, and improved cosmesis 3 . de Quadros et al 25 randomized the facial sides of 15 patients to receive botulinum toxin diluted with normal saline or reconstituted with lidocaine and epinephrine; in their study, 3 (20.0%) patients reported pain regarding the side treated with lidocaine, whereas 8 (53.3%) reported pain in the side incorporated with normal saline. Although this difference did not reach the significance level ( P = 0.180), there might be a chance to see a statistically significant result if a larger number of patients had been enrolled.…”