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Pain Associated With Injection of Botulinum A Exotoxin Reconstituted Using Isotonic Sodium Chloride With and Without Preservative
A Double-blind, Randomized Controlled Trial
Murad Alam, MD;
Jeffrey S. Dover, MD, FRCPC;
Kenneth A. Arndt, MD
Arch Dermatol. 2002;138:510-514.
Context Botulinum A exotoxin is used for various indications, including the
treatment of dynamic forehead lines.
Objective To determine whether injection with botulinum A exotoxin reconstituted
with preservative-containing normal saline (isotonic sodium chloride) is less
painful than injection with exotoxin that has been reconstituted with preservative-free
saline.
Design Two arms: (1) retrospective study; (2) double-blind, randomized controlled
trial.
Setting A multiple-physician dermatology practice.
Patients (1) Retrospective study20 consecutive adult patients presenting
for treatment of upper-face dynamic lines; (2) prospective study15
consecutive adult patients presenting for treatment of upper-face dynamic
lines.
Intervention In prospective study only, one side (left or right) of the face was
treated with exotoxin reconstituted with preservative-containing saline, and
the other side, with exotoxin reconstituted with preservative-free saline.
Main Outcome Measures (1) Retrospective studydiscomfort at current treatment (with
preservative-containing saline) compared with discomfort with most recent
prior treatment (with preservative-free saline); (2) prospective studydiscomfort
on the side treated with preservative-containing saline compared with discomfort
on the side treated with preservative-free saline.
Results (1) Retrospective study18 (90%) of 20 patients reported that
treatment with exotoxin reconstituted with preserved saline was less painful
than prior treatment with exotoxin reconstituted with preservative-free saline;
(2) prospective study15 (100%) of 15 patients reported less pain in
the side of their face treated with exotoxin reconstituted with preservative-containing
saline (P<.001). Pain on the preservative-containing
side was 54% less. No difference in treatment efficacy between the sides was
observed by investigators or patients.
Conclusion Use of preservative-containing saline to reconstitute botulinum A exotoxin
can significantly decrease patient discomfort on injection.
From SkinCare Physicians, Chestnut Hill (Drs Alam, Dover, and Arndt),
and Harvard Medical School, Boston (Dr Arndt), Mass; and Dartmouth Medical
School, Hanover, NH (Drs Dover and Arndt).
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