TY - JOUR
T1 - Pain difference associated with injection of abobotulinumtoxinA reconstituted with preserved saline and preservative-free saline
T2 - A prospective, randomized, side-by-side, double-blind study
AU - Allen, Shawn B.
AU - Goldenberg, Neil A.
PY - 2012/6/1
Y1 - 2012/6/1
N2 - BACKGROUND: The Food and Drug Administration has approved the reconstitution of botulinum toxin A with preservative-free saline. Reconstitution of onabotulinumtoxinA with preserved saline has been previously reported to decrease the pain of injections. We present the first split-face study investigating differences in subjective pain when using preserved and preservative-free saline as the reconstituent of choice for abobotulinumtoxinA. OBJECTIVE: To determine whether patients notice a difference in pain when injecting abobotulinumtoxinA diluted with preserved saline versus preservative-free saline. MATERIALS AND METHODS: A prospective, randomized, double-blind, side-by-side trial was conducted in a private practice dermatology office in Boulder, Colorado. Twenty volunteer patients received injections on one side of their face with abobotulinumtoxinA reconstituted with preservative-free saline and with abobotulinumtoxinA reconstituted with preserved saline on the other side. Patients reported their pain on a 10-point visual analogue pain scale after each side was injected. Patients kept a diary for the first 48 hours after treatment to track any continued pain, onset of action, or adverse events. Patients were seen at a follow-up visit at 2 weeks, and any adverse events were recorded. RESULTS: Ninety percent of patients reported less pain on the side injected with preserved saline than on the side injected with preservative-free saline. Pain on the preserved saline side was 60% less than on the preservative-free side. Neither the patients nor the investigators noted any difference in onset of action between the two sides. CONCLUSIONS: Reconstitution of abobotulinumtoxinA with preserved saline results in significantly less pain on injection than with preservative-free saline. Preserved saline may be the reconstituent of choice for reconstitution of abobotulinumtoxinA.
AB - BACKGROUND: The Food and Drug Administration has approved the reconstitution of botulinum toxin A with preservative-free saline. Reconstitution of onabotulinumtoxinA with preserved saline has been previously reported to decrease the pain of injections. We present the first split-face study investigating differences in subjective pain when using preserved and preservative-free saline as the reconstituent of choice for abobotulinumtoxinA. OBJECTIVE: To determine whether patients notice a difference in pain when injecting abobotulinumtoxinA diluted with preserved saline versus preservative-free saline. MATERIALS AND METHODS: A prospective, randomized, double-blind, side-by-side trial was conducted in a private practice dermatology office in Boulder, Colorado. Twenty volunteer patients received injections on one side of their face with abobotulinumtoxinA reconstituted with preservative-free saline and with abobotulinumtoxinA reconstituted with preserved saline on the other side. Patients reported their pain on a 10-point visual analogue pain scale after each side was injected. Patients kept a diary for the first 48 hours after treatment to track any continued pain, onset of action, or adverse events. Patients were seen at a follow-up visit at 2 weeks, and any adverse events were recorded. RESULTS: Ninety percent of patients reported less pain on the side injected with preserved saline than on the side injected with preservative-free saline. Pain on the preserved saline side was 60% less than on the preservative-free side. Neither the patients nor the investigators noted any difference in onset of action between the two sides. CONCLUSIONS: Reconstitution of abobotulinumtoxinA with preserved saline results in significantly less pain on injection than with preservative-free saline. Preserved saline may be the reconstituent of choice for reconstitution of abobotulinumtoxinA.
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U2 - 10.1111/j.1524-4725.2011.02284.x
DO - 10.1111/j.1524-4725.2011.02284.x
M3 - Article
C2 - 22268727
AN - SCOPUS:84861816527
SN - 1076-0512
VL - 38
SP - 867
EP - 870
JO - Dermatologic Surgery
JF - Dermatologic Surgery
IS - 6
ER -