Trial reportScientific reports2023
Effects of lidocaine incorporation (without epinephrine) on pain and 2-week complications of botulinum toxin: a double-blind randomized placebo-controlled clinical trial.
Trial report in Scientific reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
1 citing paper in PubMed, 3 citations in OpenAlex.
- Effects of botulinum toxin dilution with isolated lidocaine (without epinephrine) on injection pain and post-operative complications: pilot randomized clinical trial.Journal of oral biology and craniofacial researchArticle
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Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
No study has assessed the effects of the incorporation of isolated lidocaine into botulinum toxin for reducing its pain or complications. Studies on the dilution of botulinum toxin with other materials are as well extremely few, small, and limited methodologically. Therefore, we aimed to evaluate, for the first time, the effects of the incorporation of lidocaine alone into botulinum toxin type A on post-injection pain and complications. In this 2-week prospective, multicenter, double-blind randomized placebo-controlled clinical trial, 729 participants (667 females) were enrolled. They were randomized into placebo and lidocaine dilutions (about 2:1), and then into two brands of toxins (Dysport versus Xeomin). Hence, there were 4 subgroups. In the 2 experimental subgroups, botulinum toxin was diluted with 2% lidocaine without adrenaline; in the 2 control subgroups, botulinum toxin was diluted with normal saline as a placebo. After injection, the pain level was recorded (as an 11-scale numerical rating scale from 0 to 10). After 2 weeks, post-injection complications were assessed based on the participants' reports and the surgeon's observations. Data were analyzed using 3-way ANCOVA, multiple binary logistic regression, and bivariable analyses (α = 0.05, β ≤ 0.1). The mean ± SD pain levels in the lidocaine group (n = 263) and the placebo group (n = 466) were 3.51 ± 2.04 and 4.15 ± 2.35, respectively. The mean ± SD pain levels in the subgroups 'Xeomin-Lidocaine (n = 61), Dysport-Lidocaine (n = 202), Xeomin-Placebo (n = 133), and Dysport-Placebo (n = 333)' were respectively 3.39 ± 1.86, 3.55 ± 2.09, 4.61 ± 2.49, and 3.97 ± 2.24. Lidocaine incorporation (P = 0.001), Dysport brand (P = 0.030), and younger age (P = 0.032) [but not sex (P = 0.406)] reduced pain. The only significant findings for 2-week complications were for the associations observed between aging with increased asymmetry (P = 0.022, OR = 1.032) and a need for a retouch (P = 0.039, OR = 1.021). Botulinum toxin dilution with lidocaine alone (without adrenaline or other ingredients) can reduce pain without affecting postinjection complications. Toxin brands may cause different extents of pain. Aging, but not sex, may increase pain. Two-week complications were not affected by any factors, except aging in the case of asymmetry and the need for a botulinum toxin retouch.
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