Cutaneous cooling to manage botulinum toxin injection-associated pain in patients with facial palsy: A randomised controlled trial

Pucks, N.; Thomas, Arthur L.; Hallam, Marc-James; Venables, Vanessa; Neville, Catriona; Nduka, Charles

doi:10.1016/j.bjps.2015.08.012

Cited by 8 publications

(3 citation statements)

References 21 publications

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“…Additionally, some reports associate cold temperatures with increased injection discomfort compared to physiologic temperatures, 4 whereas other reports indicate cold temperatures may have an anesthetic effect, termed cryoanalgesia. 5 Hence, a key objective was to determine the feasibility and tolerability of ice injections.…”

Section: Introductionmentioning

confidence: 99%

Injection Cryolipolysis: First-in-human Study

Kandula

Javorsky²,

Austen

et al. 2021

Plastic and Reconstructive Surgery - Global Open

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Background: Injection cryolipolysis using an ice slurry has been hypothesized to be a novel method of reducing fat. The present first-in-human pilot study aims to investigate the feasibility, safety, and tolerability of ice slurry injection into human subcutaneous fat. Methods: Preabdominoplasty subjects were recruited. Baseline measurements and serial follow-up visits following a single ice slurry injection procedure into tissue to be excised during abdominoplasty were performed. Melted ice slurry injection was used as control. Feasibility using standard injection techniques was assessed. Thermal imaging was used to determine cooling efficacy. Safety was assessed by adverse event monitoring. Tolerability was assessed by subject-reported pain score. Histology and ultrasound were monitored for structural changes associated with cryolipolysis. Results: A single injection of ice slurry was feasible and sufficient to cool adipose below the target temperature (10C). There were no serious adverse events. The most common adverse events were bruising and erythema. The mean pain score for ice slurry-injected sites was 1.9/10 and 1.3/10 in control injection sites. Evidence of cryolipolysis was observed on ultrasound and tissue histology in ice slurry-injected sites. Conclusions: Ice slurry injections are feasible, with an observed safety and tolerability profile comparable to topical cryolipolysis. The ice slurry can cool tissue to induce cryolipolysis, as observed by thermal imaging, ultrasound, and tissue histology, and is selective for ice-injected sites. No significant changes were observed in control sites. The ice slurry may be a promising candidate to enable more precise, effective, and customizable aesthetic fat reduction that warrants further investigation.

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Section: Introductionmentioning

confidence: 99%

Injection Cryolipolysis: First-in-human Study

Kandula

Javorsky²,

Austen

et al. 2021

Plastic and Reconstructive Surgery - Global Open

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“…Furthermore, different cuts from different providers were not compared in the study at hand, as the cut of a needle might have considerable impact on individual pain perception. Another aspect that has not been addressed in this study was individual treatment strategies to minimize discomfort like pre-injection cooling [17] or vibration devices [18]. In addition, the study at hand lacks internal controls to correct for individuals who may be more prone to subjective pain.…”

Section: Discussionmentioning

confidence: 99%

Subjective Discomfort during Botulinumtoxin Injections Dependent on Injection Site and Needle Size: A Comparison Between 30G, 33G and 34G Needles

Kämmerer,

Bertlich,

Hartmann

et al. 2024

Aesth Plast Surg

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Background Botulinumtoxin application in the face is amongst the most common aesthetic procedures in the head and neck region. It also has numerous medical uses. One of the main reasons for patients to refrain from it is the subjective discomfort that is experienced during injections. Objectives The study at hand aimed to determine whether needles with 33G and 34G offer an advantage in terms of individual pain perception during botulinumtoxin injections. Methods We conducted a prospective study where patients were asked to grade subjective discomfort on a visual analogue scale for each region (forehead, glabella, temple) that was treated directly after treatment and 15 minutes after. Patients were treated with 30G, 33G or 34G needles, respectively. Results Ninety-nine patients that underwent treatment of 189 regions were included in the study. Patients were evenly distributed amongst the different needle sizes and regions. Subjective discomfort was greatest in all regions for 30G needles (3.9 ± 1.6 forehead, 4.3 ± 1.7 glabella and 4.0 ± 1.6 temple) followed by 33G (2.7 ± 1.5 forehead, 2.7 ± 1.9 glabella and 2.2 ± 1.2 temple) and 34G (1.7 ± 1.2 forehead, 1.6 ± 1.4 glabella and 1.6 ± 1.4 temple). All differences between needle size were statistically significant (p < 0.05) Conclusion 33G and 34G needles seem to offer smaller discomfort during BTX treatments of the head and neck, with 34G being superior to 33G. Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266

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“…In the next randomized study with 35 patients, researchers analyzed the analgesic effect of applying a cold gel pack (3-5 • C) for one minute using the VAS versus using a control gel pack (room temperature, 20 • C) before injecting the BoNT. The cold packs provided a statistically significant reduction in pain [31].…”

Section: Facial Paralysismentioning

confidence: 92%

Use of Botulinum Toxin in Orofacial Clinical Practice

Serrera-Figallo

Ruiz-de-León-Hernández

Torrés-Lagares

et al. 2020

Toxins

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Introduction: Botulinum neurotoxin (BoNT) is a potent biological toxin and powerful therapeutic tool for a growing number of clinical orofacial applications. BoNT relaxes striated muscle by inhibiting acetylcholine’s release from presynaptic nerve terminals, blocking the neuromuscular junction. It also has an antinociceptive effect on sensory nerve endings, where BoNT and acetylcholine are transported axonally to the central nervous system. In dentistry, controlled clinical trials have demonstrated BoNT’s efficiency in pathologies such as bruxism, facial paralysis, temporomandibular joint (TMJ) disorders, neuropathic pain, sialorrhea, dystonia and more. Aim: This study’s aim was to conduct a systematic literature review to assess the most recent high-level clinical evidence for BoNT’s efficacy and for various protocols (the toxin used, dilution, dosage and infiltration sites) used in several orofacial pathologies. Materials and methods: We systematically searched the MedLine database for research papers published from 2014 to 2019 with randomly allocated studies on humans. The search included the following pathologies: bruxism, dislocation of the TMJ, orofacial dystonia, myofascial pain, salivary gland disease, orofacial spasm, facial paralysis, sialorrhea, Frey syndrome and trigeminal neuralgia. Results: We found 228 articles, of which only 20 met the inclusion criteria: bruxism (four articles), orofacial dystonia (two articles), myofascial pain (one article), salivary gland disease (one article), orofacial spasm (two articles), facial paralysis (three articles), sialorrhea (four articles) or trigeminal neuralgia (three articles). Discussion: The clinical trials assessed showed variations in the dosage, application sites and musculature treated. Thus, applying BoNT can reduce symptoms related to motor muscular activity in the studied pathologies efficiently enough to satisfy patients. We did not identify the onset of any important side effects in the literature reviewed. We conclude that treatment with BoNT seems a safe and effective treatment for the reviewed pathologies.

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Cutaneous cooling to manage botulinum toxin injection-associated pain in patients with facial palsy: A randomised controlled trial

Cited by 8 publications

References 21 publications

Injection Cryolipolysis: First-in-human Study

Injection Cryolipolysis: First-in-human Study

Subjective Discomfort during Botulinumtoxin Injections Dependent on Injection Site and Needle Size: A Comparison Between 30G, 33G and 34G Needles

Use of Botulinum Toxin in Orofacial Clinical Practice

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