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

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.