Pain difference associated with injection of abobotulinumtoxinA reconstituted with preserved saline and preservative-free saline: a prospective, randomized, side-by-side, double-blind study.

Abstract

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.

• Authors: Shawn B Allen, Neil A Goldenberg
• Journal: Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] (Dermatol Surg) Vol. 38 Issue 6 Pg. 867-70 (Jun 2012) ISSN: 1524-4725 [Electronic] United States
• PMID: 22268727 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

Chemical References

• Drug Combinations
• Isotonic Solutions
• Neuromuscular Agents
• Preservatives, Pharmaceutical
• Sodium Chloride
• Botulinum Toxins, Type A
• abobotulinumtoxinA

Topics

• Adult
• Aged
• Botulinum Toxins, Type A (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Combinations
• Face
• Female
• Follow-Up Studies
• Humans
• Injections
• Isotonic Solutions (administration & dosage)
• Male
• Middle Aged
• Neuromuscular Agents (administration & dosage, adverse effects)
• Pain (chemically induced, diagnosis, prevention & control)
• Pain Measurement
• Preservatives, Pharmaceutical (administration & dosage)
• Prospective Studies
• Sodium Chloride (administration & dosage)
• Young Adult