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Original Investigation |

Effect of Needle Size on Pain Perception in Patients Treated With Botulinum Toxin Type A Injections A Randomized Clinical Trial

Murad Alam, MD, MSCI1,2,3; Amelia Geisler, BS1; Divya Sadhwani, MD1; Amita Goyal, MD1; Emily Poon, PhD1; Michael Nodzenski, MS1; Matthew R. Schaeffer, BA1; Rebecca Tung, MD4; Kira Minkis, MD, PhD5
[+] Author Affiliations
1Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
2Department of Otolaryngology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
3Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
4Division of Dermatology, Loyola University, Maywood, Illinois
5Department of Dermatology, Weill Cornell Medical College, New York, New York
JAMA Dermatol. 2015;151(11):1194-1199. doi:10.1001/jamadermatol.2015.2232.
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Importance  Transcutaneous injection through smaller hollow-bore needles may decrease patient discomfort, but current evidence is equivocal.

Objective  To compare injection discomfort in patients treated with botulinum toxin type A with 30- and 32-gauge needles.

Design, Setting, and Participants  Split-face, patient- and injector-blinded randomized clinical trial at the dermatology service of an urban university medical center. The 20 participants were women aged 25 to 70 years in good health and with moderate dynamic forehead and glabellar wrinkles. Data were collected from November 20, 2013, through January 16, 2014. Follow-up was complete on January 16, 2014. Data from the per-protocol population were analyzed from July 1 to July 31, 2014.

Interventions  One side of each patient’sforehead received botulinum toxin type A in saline injected with a 32-gauge needle; the other side received the same treatment injected with a 30-gauge needle. In addition, each patient received randomized injections of saline only to both upper inner arms with the same types of needles.

Main Outcomes and Measures  Primary outcomes included the patient-reported pain rating on a visual analog scale (VAS) on either side of the face and arms and the proportion of patients whose VAS ratings corresponded with more than moderate (ie, clinically significant) pain. The secondary outcome consisted of patient-reported information about the character of the pain at both sites using the expanded and revised version of the Short-Form McGill Pain Questionnaire.

Results  All 20 patients completed the study. Overall, facial and arm injections were nominally but not significantly more painful with 30-gauge needles (mean [SD] VAS ratings for the face, 4.16 [2.55] vs 3.41 [2.31], P = .34; for the arm, 1.66 [2.07] vs 1.21 [1.65], P = .45). For facial injections, the likelihood of clinically significant pain (VAS rating, ≥5.4) was significantly greater with 30-gauge needles, which were associated with such pain in 8 patients (40%) compared with the 32-gauge needles, which were associated with such pain in 3 patients (15%) (odds ratio, 3.80 [95% CI, 1.05-13.78]; P = .04). No difference was found in the character of pain associated with needle bore (P > .05 for all comparisons).

Conclusions and Relevance  For facial injections of neurotoxin in saline, 30-gauge needles were associated with greater incidence of clinically significant pain than 32-gauge needles. For patients prone to experience clinically significant pain with facial injections, use of 32-gauge needles may minimize this discomfort.

Trial Registration  clinicaltrials.gov Identifier: NCT01981174

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