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Effectiveness and safety of oral sedation in adult patients undergoing dental procedures: protocol for a systematic review.

ABSTRACT: INTRODUCTION:The management of anxious patients undergoing dental procedures is still a challenge in clinical practice. Despite a wide variety of drugs for oral sedation in adult patients, there are relatively few systematic reviews that compare the effectiveness and safety of different drugs administered via this route. Thus, this study will evaluate the effectiveness and safety of oral sedation with benzodiazepines and other agents to patients undergoing dental surgical procedures. METHOD/DESIGN:We will conduct a systematic review and, if appropriate, a meta-analysis of randomised controlled clinical trials that will evaluate the use of conscious sedation administered orally to adult patients undergoing oral surgery. The search will be conducted using electronic databases, such as the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), CINAHL (via Ovid), Lilacs (SciELO) and Capes database, without restriction of languages or date of publication. Primary outcomes include anxiety, sedation, treatment satisfaction, pain and adverse effects. Secondary outcomes include vital parameters (heart rate, respiratory rate and blood pressure) and patient cooperation during intervention. A team of reviewers will independently assess each citation for eligibility and in duplicates. For eligible studies, the same reviewers will perform data extraction, risk of bias assessment and determination of the overall quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation classification system. ETHICS AND DISSEMINATION:The evidence gathered from this study should provide dental surgeons with knowledge on the effectiveness and safety of oral sedation in adults requiring dental surgical procedures. This in turn should contribute towards the decision-making process in dental practice, minimising the risks of anxiety and ineffective pain control in clinical procedures, as well as possible side effects. Ethics approval is not required in protocols for systematic reviews. The systematic review will be published in a peer-reviewed journal and presented at conferences. PROSPERO REGISTRATION NUMBER:CRD42017057142.

SUBMITTER: Araujo JO

PROVIDER: S-EPMC5780706 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Effectiveness and safety of oral sedation in adult patients undergoing dental procedures: protocol for a systematic review.

Araújo Jimmy de Oliveira JO Motta Rogério Heládio Lopes RHL Bergamaschi Cristiane de Cássia CC Guimarães Caio Chaves CC Ramacciato Juliana Cama JC de Andrade Natalia Karol NK Fiqueiró Mabel Fernandes MF Lopes Luciane Cruz LC

BMJ open 20180113 1

<h4>Introduction</h4>The management of anxious patients undergoing dental procedures is still a challenge in clinical practice. Despite a wide variety of drugs for oral sedation in adult patients, there are relatively few systematic reviews that compare the effectiveness and safety of different drugs administered via this route. Thus, this study will evaluate the effectiveness and safety of oral sedation with benzodiazepines and other agents to patients undergoing dental surgical procedures.<h4> ...[more]

PMID: 29331966

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Project description:ObjectivesIt can be challenging to manage patients who are anxious during dental procedures. There is a lack of evidence regarding the effectiveness and safety of oral sedation in adults. This study evaluated the effectiveness and safety of oral sedation in patients undergoing dental procedures.DesignSystematic review.MethodsRandomised clinical trials (RCTs) compared the oral use of benzodiazepines and other medications with a placebo or other oral agents in adult patients. A search of the Cochrane (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid) and Cumulative Index to Nursing and Allied Health Literature (via Ovid) databases was conducted, without any restrictions on language or date of publication. The primary outcomes included the adverse effects and anxiety level. The secondary outcomes included sedation, satisfaction with the treatment, heart rate, respiratory rate, blood pressure and oxygen saturation. Reviewers, independently and in pairs, assessed each citation for eligibility, performed the data extraction and assessed the risk of bias. A narrative synthesis of the data was provided.ResultsA number of RCTs (n=327 patients) assessed the use of benzodiazepines (n=9) and herbal medicines (n=3). We found good satisfaction with treatment after the use of midazolam 7.5 mg or clonidine 150 µg and reduced anxiety with alprazolam (0.5 and 0.75 mg). Midazolam 15 mg promoted greater anxiety reduction than Passiflora incarnata L. 260 mg, while Valeriana officinalis 100 mg and Erythrina mulungu 500 mg were more effective than a placebo. More patients reported adverse effects with midazolam 15 mg. Diazepam 15 mg and V. officinalis 100 mg promoted less change in the heart rate and blood pressure than a placebo.ConclusionsGiven the limitations of the findings due to the quality of the included studies and the different comparisons made between interventions, further RCTs are required to confirm the effectiveness and safety of oral sedation in dentistry.Prospero registration numberCRD42017057142.

Project description:INTRODUCTION:The use of vasoconstrictors combined with local anaesthetics (LAs) in dentistry for patients with cardiovascular disease (CVD) is still controversial in the scientific literature. It raises concerns regarding the possibility of transient episodes, triggering negative cardiovascular outcomes. METHOD/DESIGN:Trials eligible for our systematic review will enrol patients with CVD who have undergone dental treatments carried out with the use of LAs by comparing two arms: LAs with vasoconstrictors and LAs without vasoconstrictors. The research will be conducted in the electronic databases, namely Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Healthstar (via Ovid), Cumulative Index to Nursing and Allied Health Literature and Web of Science, from their inception to December 2017, without any restrictions in terms of language and status of publication. A team of reviewers will independently assess titles, abstracts and complete text to determine eligibility. For eligible studies, the same reviewers will perform data extraction and evaluate the risk of bias in the selected articles. The selected outcomes comprise death, mortality by a specific cause, stroke, acute myocardial infarction, hospitalisation, pain, bleeding, arrhythmias, ischaemic episodes, anxiety, adverse effects, changes in blood pressure, changes in heart rate, anxiety and results obtained via oximetry. Whenever possible, we will conduct a meta-analysis to establish the effects of LAs with and without vasoconstrictors in the patients with CVD, and the overall quality of evidence for each outcome will be determined using the Grading of Recommendations Assessment, Development and Evaluation classification system. ETHICS AND DISSEMINATION:Ethics committee approval was not necessary because this is a protocol of systematic review. This systematic review will be submitted for presentation at conferences and for publication in a peer-reviewed journal. Our review will assess the risks of cardiovascular events when using LAs with and without vasoconstrictors in patients with CVD, focusing on important clinical outcomes. PROSPERO REGISTRATION NUMBER:CRD42016045421.

Project description:IntroductionLive Broadcast of Surgical Procedures (LBSP) has gained popularity in conferences and educational meetings in the past few decades. This is due to rapid advancement in both Minimally Invasive Surgery (MIS) that enable transmission of the entire operative field and transmission ease and technology to help broadcast the operation to a live audience. The aim of this study was to update the evidence with specific emphasis on the patient safety issues related to LBSP in MIS.MethodsA systematic review of the literature was performed using Medline, Embase and Pubmed using defined search terms related to LBSP in educational events across all surgical specialities, in accordance with the PRISMA guidelines. We also consolidated the prior guidelines and position statements on this topic. Outcomes included reports on the educational value of LBSP as well as patient safety outcomes and ethical issues that were captured by clinical outcomes.ResultsA total 1230 abstracts were identified with 27 papers meeting the inclusion criteria (13 original articles and 14 position statements/guidelines). All studies highlighted the educational benefits of LBSP but without clear measure of these benefits. Clinical outcomes were not compromised in 9 studies but were inferior in the remaining 4, including lower completion rate of endoscopic surgery and higher rate of re-operation. Only nine studies complied with dedicated consent forms for LBSP with no consistent approach of reporting on maintaining patient confidentiality during LBSP. There was a lack of recommendation on standardised approach of reporting on LBSP including the outcomes across the 14 published guidelines and positions statements.ConclusionsLive Broadcast of Surgical Procedures can be of educational value but patient safety may be compromised. A standardised framework of reporting on LBSP and its outcomes is required from an ethical and patient safety perspective.Prospero registrationCRD42021256901.

Project description:The recent COVID-19 pandemic has underscored the necessity of protecting health care providers (HCPs) against the transmission of infectious agents during dental procedures. To this end, the effectiveness of several air cleaning devices (ACDs) in reducing HCPs exposure to aerosols generated during dental procedures was estimated, separately or in combination with each other. These ACDs were a chairside unit capturing aerosols at the source of generation, and four ambient ACDs: a portable ambient ACD; a negative pressure module; a custom made, fan-operated and wall-mounted air filter (WMAF); and a smaller and passive version of the latter. The last three ACDs were intended for mobile dental clinics (MDCs) only. This assessment was performed in two different environments: in a dental clinic operatory and in a MDC. Two dental personnel, acting in the roles of dentist and dental assistant, performed on simulated patient aerosol-generating and non-aerosol-generating procedures. For each 5-minute scenario, the cumulative exposure to airborne particulate matter 10 µm in size or smaller (PM10) was determined by calculating the sum of all 1 second readings obtained with personal and ambient air monitors. The effectiveness of the ACDs in capturing PM10 was estimated based on the capability of the ACDs to keep PM10 level at or below the initial background level. In all conditions assessed in the dental clinic operatory, when both the chairside and portable ambient ACDs were functioning, an estimated effectiveness of 100% in capturing PM10 was achieved. In the MDC, in all conditions where the chairside ACD was used without the negative pressure module, an estimated effectiveness of 100% was also achieved. The simultaneous operation of the negative pressure module in the MDC, which led to a room negative pressure of -0.25 inch wc, reduced the chairside ACD's effectiveness in capturing aerosols. Conversely, the use of the WMAF in the MDC in combination with the chairside ACD further reduced exposure to PM10 below the initial background level. Nonetheless, in all conditions assessed in both settings (dental clinic operatory and MDC), larger visible aerosols were produced, often landing on the surrounding environment. A fair portion of these aerosols landed on the inside of the chairside ACD flange. This assessment suggests that the use of the tested chairside ACD, by capturing aerosols at the source of generation, had the greatest impact on reducing exposure of dental personnel to PM10 produced during dental procedures. This study also indicates that such exposure is further reduced with the addition of an ambient ACD. However, creating a negative pressure room as high as -0.25 inch wc can lead to air turbulence reducing the effectiveness of ACDs in capturing aerosols at the source. Furthermore, the presence of uncaptured droplets and spatter on the surrounding environment supports the need to complement the use of engineering controls with proper administrative controls and personal protective equipment, as recommended by governmental agencies and the scientific community for preventing the transmission of infection in health care settings.

Project description:ObjectivesThere is a lack of evidence about the use of local anaesthetics (LAs) in patients with cardiovascular diseases (CVD) in dental procedures. Thus, this study evaluated the safety of using LA with vasoconstrictor to determine the risk of cardiovascular events in patients with CVD.DesignSystematic review and meta-analysis.MethodsWe have searched in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), Healthstar (via Ovid), CINAHL, Web of Science and ClinicalTrials.gov for randomised controlled trials (RCTs) up to January 2020. We have included RCTs involving adults with CVD within two groups: intervention group with LA with vasoconstrictor and control group with LA without vasoconstrictor. The primary outcomes assessed were death, mortality by a specific cause, stroke, acute myocardial infarction, hospitalisation, pain, bleeding and arrhythmias. The secondary outcomes were ST segment depression, anxiety, adverse effects and changes in haemodynamic parameters. The data were pooled using random effects meta-analyses and the confidence in the estimates was verified using the Grading of Recommendations Assessment, Development and Evaluation (GRADE).ResultsTen RCTs (n=478 participants) were included. Most of them had a high risk of bias. There were more cases of pain and bleeding in groups without vasoconstrictor. Meta-analysis demonstrated a decrease in the systolic blood pressure with the use of LA with vasoconstrictor (standard mean difference -0.95, 95% CI -1.35 to -0.55) after procedure. Overall, for the other outcomes assessed there was no statistical difference. The quality of evidence was considered low according to the GRADE profile.ConclusionsThe results suggest that the use of LA with vasoconstrictors (epinephrine in low doses) is safe in patients with some types of CVD. However, the low quality of evidence demonstrated that literature needs further studies in order to confirm these results.Protocol registrationPROSPERO (CRD42016045421).

Project description:Sucrose is widely used to manage procedural pain in term newborns despite a lack of evidence of its effectiveness for different procedures and infant populations. Our objectives were to evaluate the effectiveness and safety of sucrose in newborns undergoing various medical procedures within 2 days of birth.We performed a double-blind, randomized controlled trial. We included newborns (>or= 36 weeks gestation) of diabetic mothers and nondiabetic mothers. Each newborn received 2 mL of a 24%-sucrose or placebo solution before all procedures. We used the Premature Infant Pain Profile to assess pain during intramuscular injection of vitamin K, venipuncture for the newborn screening test and the first 3 heel lances for glucose monitoring (newborns of diabetic mothers only). Scores ranged from from 0 (no pain) to 18 (maximum pain).We included 240 newborns (120 from diabetic mothers, 120 from nondiabetic mothers). The overall mean pain score was lower among newborns who received sucrose than among those who received a placebo (mean difference -1.3, 95% confidence interval [CI] -2.0 to -0.6). We found that pain scores during intramuscular injection did not differ significantly between the sucrose and placebo groups for newborns of diabetic or nondiabetic mothers (newborns of nondiabetic mothers: mean difference -1.1, 95% CI -2.4 to 0.2; newborns of diabetic mothers: mean difference -1.0, 95% CI -2.4 to 0.4). During venipuncture, newborns who received sucrose had lower pain scores compared with those who received a placebo (newborns of nondiabetic mothers: mean difference -3.2, 95% CI -4.6 to -1.8; newborns of diabetic mothers: mean difference -2.4, 95% CI -3.8 to -1.0). Among newborns of diabetic mothers, there was no difference in pain during the first 3 heel lances or mean glucose levels between the sucrose and placebo groups (p = 0.94 and p = 0.29 respectively).We found a modest reduction of pain in newborns of both diabetic and nondiabetic mothers when sucrose was used for all medical procedures performed in the first 2 days after birth. However, when each procedure was analyzed separately, we found that the effectiveness of sucrose was limited to venipuncture for the newborn screening test. (http://Clinicaltrials.gov trial register no. NCT00213213.).

Dataset Information

Effectiveness and safety of oral sedation in adult patients undergoing dental procedures: protocol for a systematic review.

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Effectiveness and safety of oral sedation in adult patients undergoing dental procedures: protocol for a systematic review.

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