Evaluating Effects of Preservative-Containing Saline Solution on Pain Perception During Botulinum Toxin Type-A Injections at Different Locations: A Prospective, Single-Blinded, Randomized Controlled Trial

Abstract

Pain is a side effect of botulinum toxin type-A (BTX-A) injections. The efficiency of the preservative-containing saline solution used as the "dilution solution" for controlling the pain felt during multiple injections in different areas has been investigated by a prospective, randomized, single-blinded, controlled study. A total of 93 patients were divided into three groups for the study. All the patients were given BTX-A. Of these 93 patients, 60 received injections in the upper face, 15 in the neck, and 18 in the axillary regions. The visual analog scale (VAS), a single-dimension pain intensity rating scale, was used to evaluate pain perception. The average VAS values for pain sensation experienced by the groups were 1.2 of 10 points for the upper face area in the experimental group (n = 60) and 4.5 point for the control group. In the neck region (n = 15), the respective scores were 0.6 in the experimental group and 3.9 in the control group. Finally, in the axillary region (n = 18), the respective values were 0.9 and 5.1. The authors conclude that the preservative-containing saline solution significantly decreased pain perception during BTX-A injections (p = 0.000).

Pain Difference Associated with Injection of AbobotulinumtoxinA Reconstituted with Preserved Saline and Preservative-Free Saline: A Prospective, Randomized, Side-by-Side, Double-Blind Study

“…In this study, there was a clear difference in pain reported for preservative‐free saline and preserved saline, with 60% less pain being reported with preserved saline. These results are consistent with previous studies reporting greater pain with preservative‐free saline than with preserved saline for reconstitution of botulinum toxins . Although botulinum toxin injections are not generally considered painful, it is clear from this study that using preservative‐free saline for reconstitution leads to greater pain.…”

“…Our study findings are consistent with prior studies examining pain differences associated with injecting botulinum toxins with preserved and preservative‐free saline . Although package inserts recommend reconstitution of botulinum toxins with preservative‐free saline, the clear evidence in our study, as well as previous literature reporting less pain with preserved saline, may make it the reconstituent of choice for reconstitution of botulinum toxins.…”

“…Package inserts indicate that Food and Drug Administration (FDA)‐approved botulinum toxin type A for cosmetic use should be reconstituted with sodium chloride without preservative (preservative‐free saline) . Prior studies have shown that injection of onabotulinumtoxinA (Botox Cosmetic, Allergan Inc., Irvine, CA) and rimabotulinumtoxinB (Myobloc, Solstice Neurosciences Inc./Eisai Co. Ltd., Woodcliff Lake, NJ) with preserved saline results in significantly less discomfort than with preservative‐free saline . No studies have been performed with abobotulinumtoxinA (Dysport, Ipsen Biopharm Ltd., Berkshire, UK) comparing pain when using preserved versus preservative‐free saline as a reconstituent.…”

Impact of Postreconstitution Room Temperature Storage on the Efficacy of IncobotulinumtoxinA Treatment of Dynamic Lateral Canthus Lines

“…Multiple studies have demonstrated that different types of BoNTA can be stored after reconstitution in a refrigerated environment (2-8°C) or frozen (210 to 220°C) for up to 2 to 6 weeks without detriment to their clinical effectiveness. 9,10 In this study, the authors sought to examine the impact of prolonged storage (7 days) of reconstituted inco-botulinumtoxinA at room temperature (25°C). 4 Because of the theoretical concern over contamination and microbial growth with multipleuse vials, Hexsel and colleagues studied the impact of prolonged postreconstitution storage of BoNTA, mixed with nonpreserved saline and stored for 15 days, on microbial growth and reported no growth for up to 10 months after reconstitution.…”

29 Aesthetic Facial Use of Botulinum Toxin in East Asians

“…19,20 Various volumes of normal saline have been used for the reconstitution of BTA powder, from 1 to 10 mL, with 2.5 mL and 3.3 mL being popular dilutions, with respective concentrations of 4 U/0.1 mL and 3 U/0.1 mL. Various results have been suggested for the effect of refrigerator storage on the potency of BTA following the reconstitution of BTA.…”