Dataset Information

Randomized Safety and Feasibility Trial of Ultra-Rapid Cooling Anesthesia for Intravitreal Injections.

ABSTRACT:

Purpose

To test the safety and preliminary efficacy of rapid, nonpharmacologic anesthesia via cooling for intravitreal injections.

Design

Single-center, randomized phase 1 dose-ranging safety study (ClinicalTrials.gov identifier, NCT02872012).

Participants

Adults 18 years of age or older with a diagnosis of exudative macular degeneration or diabetic macular edema requiring bilateral anti-vascular endothelial growth factor therapy were included.

Methods

A handheld device was developed to provide anesthesia via cooling to a focal area on the surface of the eye before intravitreal treatment (IVT). In 22 patients undergoing bilateral IVT, 1 eye was randomized to receive standard of care (SOC) lidocaine-based anesthesia and the other eye received cooling-anesthesia at 1 of 5 different temperatures and cooling times. Subjective pain was assessed via the visual analog scale (VAS; range, 1-10) at 2 time points: (1) immediately after IVT and (2) 4 hours after IVT. Treated eyes were assessed for ocular safety 24 hours after IVT.

Main outcome measures

We determined the occurrence of adverse events in eyes treated with cooling anesthesia. Mean VAS pain scores immediately after IVT and 4 hours after IVT in eyes receiving cooling anesthesia were compared with eyes receiving SOC.

Results

A total of 44 eyes were treated, 22 with cooling anesthesia and 22 with SOC. No dose-related toxicity was found with cooling anesthesia. Mild, transient adverse events were recorded in 32% of patients treated with cooling anesthesia versus 44% of patients receiving SOC. The mean±standard error of the mean (SEM) VAS pain scores immediately after intravitreal injection were 2.3 ± 0.4 for patients receiving SOC and 2.2 ± 0.6 in patients receiving -10° C cooling anesthesia (P = 0.8). Mean±SEM pain scores 4 hours after injection were 1.6 ± 0.4 for SOC and 1.2 ± 0.5 in the combined -10° C arms (P = 0.56). Total mean±SEM procedure time was 124 ± 5 seconds for patients treated with cooling anesthesia versus 395 ± 40 seconds for SOC (P < 0.0001).

Conclusions

Ultra-rapid cooling of the eye for anesthesia was well tolerated, with -10° C treatment resulting in comparable levels of anesthesia to SOC with a reduction in procedure time.

SUBMITTER: Besirli CG

PROVIDER: S-EPMC7541410 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Intravitreal injection (IVI) is a very common vitreoretinal procedure, and multiple injections are often required per patient. This systematic review was conducted to evaluate the effectiveness of various local anesthetic techniques in reducing pain during injection. METHODS:A systematic review was conducted based on searches of Cochrane, LILACS, PubMed, Scopus, Web of Science, and the gray literature (Google Scholar). The end search date was February 19, 2016, across all databases. We classified pain by converting visual analog scale (VAS) scores (0-100 mm) into Jensen's classification levels: 0-4, no pain; 5-44, mild pain; 45-74, moderate pain; and 75-100, severe pain. An intervention was considered clinically significant when pain score change was >12 mm on a 100-mm scale. RESULTS:Eight studies out of 23 met the eligibility criteria. The total number of patients was 847. Most studies (5/8 [62.5%]) were at unclear risk of bias because of unclear randomization, thus providing only moderate evidence to this review. The anesthetic techniques included eye drops with proparacaine, tetracaine or cocaine, a lidocaine pledget or gel, and subconjunctival injection of 2% lidocaine or 0.75% levobupivacaine. No study comprised all of the techniques. Pain was mild (VAS scores, 5-44 mm) regardless of anesthetic technique. A clinically significant intervention (pain score change >12 mm) was found for only one study comparing proparacaine drops, lidocaine gel, and subconjunctival lidocaine; in that study, a subconjunctival injection of 2% lidocaine provided the greatest pain reduction. A meta-analysis was not possible due to study heterogeneity. CONCLUSIONS:Patient pain during IVI under topical anesthesia is mild regardless of anesthetic technique. A subconjunctival injection of 2% lidocaine could be an option for highly sensitive patients. However, with moderate level of evidence, no single anesthetic technique could be defined as the best option for IVI.