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Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial.

ABSTRACT: INTRODUCTION:A current non-pharmacological mean for attaining painless local anaesthesia (LA) is presented by vibrotactile devices. Their concept is to reduce injection pain due to distraction by applying physical stimuli which interfere with pain signals. The aim of this study is to determine the efficacy of the DentalVibe (DV) device in reducing pain and anxiety associated with LA in paediatric patients. METHODS AND ANALYSIS:The proposed study is a randomised controlled clinical trial with split-mouth design. Included are positive patients aged 8-12 years, requiring buccal infiltration for extraction of two bilateral primary maxillary molars. After dental fear measurement, eligible patients undergo two single-visit treatments with DV device allocated to either first or second LA via computer-generated randomisation sequence. Outcome measures will be self-reported pain felt during LA on Visual Analogue Scale; self-reported anxiety on Facial Image Scale; pain-related behaviour according to Faces, Legs, Activity, Cry, Consolability Scale; heart rate; patient preference to LA technique.Data will be analysed with intention-to-treat concept by Student's t-test for paired samples, Wilcoxon signed-rank test, p<0.05. Pretest on 20 subjects resulted in n=41 patients sample size. ETHICS AND DISSEMINATION:This study protocol has been approved by the Committee for Scientific Research Ethics, Medical University - Plovdiv, Bulgaria (Reference number P-8604, Protocol of approval No. 6/23.11.2017) and registered on a publicly accessible database. This research received institutional funding from the Medical University - Plovdiv, Bulgaria, under project SPD-03/2017. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants. TRIAL REGISTRATION NUMBER:NCT03445182; Pre-results.

SUBMITTER: Veneva E

PROVIDER: S-EPMC6609117 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial.

Veneva Elitsa E Cholakova Radka R Raycheva Ralitsa R Belcheva Ani A

BMJ open 20190702 7

<h4>Introduction</h4>A current non-pharmacological mean for attaining painless local anaesthesia (LA) is presented by vibrotactile devices. Their concept is to reduce injection pain due to distraction by applying physical stimuli which interfere with pain signals. The aim of this study is to determine the efficacy of the DentalVibe (DV) device in reducing pain and anxiety associated with LA in paediatric patients.<h4>Methods and analysis</h4>The proposed study is a randomised controlled clinical ...[more]

PMID: 31270121

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Project description:BackgroundPeripheral 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.MethodsOne 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.ResultsA 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.ConclusionIntradermal injection of anaesthetic with Micronjet600 was found to be a safe and effective option for providing rapid local anesthesia for peripheral intravenous cannulation.Trial regiatrationThe 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.

Project description:ObjectivesTo determine whether administration of local anaesthetic at the site of skin incision during open lacrimal drainage surgery under general anaesthesia alters the total dosage of anaesthetic drugs required during total intravenous anaesthesia (TIVA), and whether it alters postoperative pain and recovery.Study designMasked comparison of a randomized, two-group interventional study.Patients and methodsPatients undergoing unilateral external dacryocystorhinostomy under total intravenous general anaesthesia were recruited from the lacrimal service at Moorfields Eye Hospital between September 2012 and February 2014. The patients were randomised to receive, after induction and stabilisation of general anaesthesia, infiltration of the ipsilateral paranasal tissues with 2.5 ml of 0.5% bupivacaine with 1:100000 epinephrine ("treatment" group), or a sham injection ("control" group); the infiltration was performed about 7 min prior to the skin incision. The infusion rates for propofol and remifentanil were adjusted to maintain a steady intra-operative mean blood pressure of 55-70 mmHg and BIS score of 40-60%. The time taken for extubation of the patient after cessation of TIVA was recorded, and postoperative pain scores (on a Likert scale from 0-10) were taken at regular intervals after extubation. The average intra-operative mean blood pressures, total drug usage, extubation time and pain scores for each of the two groups were compared using two-tail Student's t-testing and Wilcoxon rank sum testing.ResultsThere were 12 patients (7 female; 58%) in the treatment group and 11 (7 female; 64%) in the control group, with similar average age at surgery (59 years treatment, 53 years control; p = 0.38) The average operative time was 45 min in the treatment group (median 42, range 30-55) and 47 min (median 45; range 37-61) in the control group (p = 0.52). The mean dosage of propofol required to maintain satisfactory GA was significantly less in the "treatment" group (89.8 mcg/kg/min) as compared to the "control" group (mean 126 mcg/kg/min) (p = 0.0007). Likewise, remifentanil dosage was significantly less in the "treatment" group (100 ng/kg/min) as compared to controls (259 ng/kg/min) (p = 0.00007). The mean non-invasive blood pressure was consistently lower during surgery in the "treated" group, and showed less intra-operative variation. After surgery, the patients receiving LA had a significantly shorter extubation time (mean time 6.0 min in "treated" group, 12.1 min in "controls"; P < 0.0002) and also significantly lower pain scores at 10, 30, 60, 120 and 180 min after extubation (p < 0.01, p < 0.01, p < 0.01, p < 0.01 and p < 0.05, respectively).ConclusionsIpsilateral infiltration of local anaesthesia containing epinephrine in the paranasal tissues just prior to open dacryocystorhinostomy under total intravenous anaesthesia is associated with a 28% reduction in mean propofol usage, and a 61% reduction in remifentanil usage. LA usage during GA also produces improved and less variable intra-operative mean blood pressures, a significantly shorter extubation time and significantly lower postoperative pain scores.

Project description:BackgroundPatients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival.Methods/designA two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; surgical adverse events, re-operation and re-admission rates; the relative cost of the two methods of anaesthesia; length of stay and intensive and high dependency bed occupancy.Trial registrationCurrent Controlled Trials ISRCTN00525237.

Project description:BackgroundLocal anesthesia (LA) poses a threat in children more than the treatment process itself, so pediatric dentists are always demanding less painful techniques. Computer-controlled Intraligamentary anaesthesia (CC-ILA) is designed to reduce injection pain and side effects of conventional techniques. The present study aims to assess the pain experience using Computer-controlled Intraligamentary anaesthesia (CC-ILA) during injection and its effectiveness in controlling pain during extraction of mandibular primary molars in pediatric patients.MethodsThis randomized controlled clinical trial includes 50 healthy cooperative children, aged 5-7 years with mandibular primary molars indicated for extraction. They were randomly allocated to two groups according to LA technique: test group received CC-ILA and control group received Inferior alveolar nerve block (IANB). Pain was measured during injection and extraction: physiologically using Heart rate (HR), subjectively using Face-Pain-Scale (FPS), and objectively using Sound-Eye-Motor scale (SEM). Patients were recalled after 24-h to record lip-biting events. Data was collected and statistically analysed.ResultsA total of 50 children (29 females and 21 males) with mean age 6.10 ± 0.76 participated in the study. There were significantly lower scores in the heart rate in the CC-ILA group during injection (p = 0.04), but no significant difference was recorded between the two groups during extraction (p = 0.17). The SEM and FPS showed significant lower scores in the CC-ILA group during injection (p < 0.0001, p < 0.0001) and extraction (p < 0.0001, p = 0.01) respectively. No children in CC-ILA group reported lip-biting after 24-h compared to 32% in IANB (p < 0.0001).ConclusionCC-ILA provides significantly less painful injections than conventional techniques and has proved to be as effective as IANB during extraction of mandibular primary molars. An important advantage of this technique was the complete absence of any lip/cheek biting events. Trial registration The study was prospectively registered in ClinicalTrials.gov with the identifier: NCT04739735 on 26th of January 2021, https://clinicaltrials.gov/ct2/show/NCT04739735 .

Dataset Information

Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial.

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Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial.

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