TY - JOUR
T1 - Pain associated with injection of botulinum A exotoxin reconstituted using isotonic sodium chloride with and without preservative
T2 - A double-blind, randomized controlled trial
AU - Alam, Murad
AU - Dover, Jeffrey S.
AU - Arndt, Kenneth A.
N1 - Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2002
Y1 - 2002
N2 - 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 study - 20 consecutive adult patients presenting for treatment of upper-face dynamic lines; (2) prospective study - 15 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 study - discomfort at current treatment (with preservative-containing saline) compared with discomfort with most recent prior treatment (with preservative-free saline); (2) prospective study - discomfort on the side treated with preservative-containing saline compared with discomfort on the side treated with preservative-free saline. Results: (1) Retrospective study - 18 (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 study - 15 (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.
AB - 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 study - 20 consecutive adult patients presenting for treatment of upper-face dynamic lines; (2) prospective study - 15 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 study - discomfort at current treatment (with preservative-containing saline) compared with discomfort with most recent prior treatment (with preservative-free saline); (2) prospective study - discomfort on the side treated with preservative-containing saline compared with discomfort on the side treated with preservative-free saline. Results: (1) Retrospective study - 18 (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 study - 15 (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.
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U2 - 10.1001/archderm.138.4.510
DO - 10.1001/archderm.138.4.510
M3 - Article
C2 - 11939813
AN - SCOPUS:0036219395
SN - 0003-987X
VL - 138
SP - 510
EP - 514
JO - Archives of Dermatology
JF - Archives of Dermatology
IS - 4
ER -