Dataset Information

Intradermal injection of lidocaine with a microneedle device to provide rapid local anaesthesia for peripheral intravenous cannulation: A randomised open-label placebo-controlled clinical trial

ABSTRACT:

Background

Peripheral venous cannulation is one of the most common procedures in medicine. It is associated with noticeable pain and apprehension, although in most cases it is performed without any anesthesia due to lack of a painless, cost-effective option, which would provide rapid local anesthesia with subsequent significant reduction in the experienced pain. We conducted an open-label placebo-controlled clinical trial to evaluate the efficacy and safety of a 2% lidocaine injection using the commercially available microneedle device MinronJet600 (NanoPass Technologies Ltd, Israel) to achieve rapid local anesthesia prior to peripheral venous cannulation.

Methods

One hundred and two subjects were randomly allocated into two groups. In the first group, 100μL of lidocaine hydrochloride (2%) was injected intradermally to subjects using the MicronJet600 device in the left arm (MJ-Lido) and 100μL of saline was injected intradermally using the device in the right arm (MJ-Saline). In the second group, 100μL of lidocaine hydrochloride (2%) was injected using the MicronJet600 device into the left arm (MJ-Lido), with no injection into the right arm of subjects (No pretreatment). In both groups the intradermal injection was performed at the cannulation site prior to insertion of a 18G cannula into a median cubital vein in both arms. As a primary variable, a score of cannulation-induced pain was indicated by subjects using a 100-point visual analog scale immediately after cannulation. As a secondary variable, subjects in Group 2 also indicated their preference to receive the anaesthetic injection with MicronJet600 in the future by using the 5-point Likert scale. Also, as a secondary variable, the duration of skin numbness after lidocaine injection was indicated by performing a superficial pin-prick with a 27G needle at 15, 30 and 45 minutes, at distances of 1, 2 and 3 centimeters from the injection site.

Results

A significant pain reduction (11.0-fold) was achieved due to the lidocaine injection compared to the cannulation without any pretreatment (p< 0.005). After the lidocaine injection the anesthesia was effective up to 2 centimeters from the injection site and remained for up to 30 minutes. Eighty percent of subjects from the second group preferred cannulation after the lidocaine injection over cannulation without any pretreatment. No significant side effects were identified.

Conclusion

Intradermal injection of anaesthetic with Micronjet600 was found to be a safe and effective option for providing rapid local anesthesia for peripheral intravenous cannulation.

Trial regiatration

The clinical trial was registered, before the patient enrollment began, in the Research Registry publicly accessible database (registration identifier: researchregistry4662). Also, the trial was registered in ClinicalTrials.gov (registration identifier: NCT05108714) after its completion.

SUBMITTER: Rzhevskiy A

PROVIDER: S-EPMC8803196 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe design of medical devices impacts upon the performance of healthcare professionals and patient safety. However, multiple devices serving the same function are often available. The purpose of this study was to use simulation as a means of examining the impact of differences in device design on (1) learning of, or attainment of behavioral fluency in, peripheral intravenous cannulation (PIVC); and (2) the generalization, or transfer, of learning on one device to performance of PIVC using an untrained device.MethodsA total of 25 final cycle medical students participated in this study which used a randomized two-group design. Participants were randomly assigned to learn PIVC using either a closed PIVC device (a single device which consists of an intravenous cannula with a pre-attached extension tube; n = 14) or an open PIVC device (a two-piece device made up of an intravenous cannula and a separate extension tube which is attached following insertion of the cannula; n = 11). Task analyses were developed for the performance of PIVC using each device. Subsequently, simulation-based fluency training was delivered to both groups using their assigned PIVC device, and continued for each participant until the fluency criterion was achieved. Following achievement of fluency, participants were asked to perform PIVC using the untrained device (i.e., the PIVC device that they had not been trained on).ResultsAll participants in both groups met the fluency criterion, and no significant differences were observed in the number of trials or total training required by groups to achieve fluency. Participants in both groups improved significantly from baseline (M = 11.69) to final training trial (M = 100). However, a significant decrement in performance (M = 81.5) was observed when participants were required to perform PIVC using the untrained device.ConclusionsParticipants achieved fluency in PIVC regardless of the device used. However, significant decrements in performance were observed when participants were required to perform PIVC using a novel device. This finding supports the need for careful consideration of devices purchased and supplied in the clinical setting, and the need for training prior to the introduction of novel devices or for new staff members.