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Randomized Controlled Trial Comparative Study
Pain difference associated with injection of abobotulinumtoxinA reconstituted with preserved saline and preservative-free saline: a prospective, randomized, side-by-side, double-blind study.
- Shawn B Allen and Neil A Goldenberg.
- Department of Dermatology, School of Medicine, University of Colorado, Denver, Colorado, USA. sallen.dsb@gmail.com
- Dermatol Surg. 2012 Jun 1;38(6):867-70.
BackgroundThe 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.ObjectiveTo determine whether patients notice a difference in pain when injecting abobotulinumtoxinA diluted with preserved saline versus preservative-free saline.Materials And MethodsA 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.ResultsNinety 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.ConclusionsReconstitution 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.© 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.
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