Nissen Katrine Dueholm, Moos Caroline Margaret, Wolf Andras, Strøm Thomas
Department of Anaesthesiology and Intensive Care, University Hospital of Southern Denmark, Aabenraa, Denmark.
Department of Clinical Research, University Hospital of Southern Denmark, Aabenraa, Denmark.
PLoS One. 2025 Jan 13;20(1):e0317406. doi: 10.1371/journal.pone.0317406. eCollection 2025.
Sedation ensures a child remains motionless during a procedure and decreases anxiety. Several pharmacologic regimes exist for paediatric sedation. However, often, intravenous cannulation is required, causing distress for the child. Creating a low-stress environment for children during medical procedures is crucial. Intranasal dexmedetomidine offers a promising alternative by either removing the need for intravenous cannulation or significantly reducing stress and anxiety when cannulation is necessary. We aim to investigate the safety and efficiency of sedating children with intranasal dexmedetomidine.
We will systematically search MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCO), CENTRAL, Clinicaltrials.gov, and the WHO ICTRP portal. We will include all randomized controlled trials (RCT) that investigate the use of intranasal dexmedetomidine compared to alternative sedatives for premedication or sedation of children. Two researchers will independently screen title/abstract and full-text articles for eligibility using Covidence. Our primary outcome is sedation success rate. RCTs that meet the inclusion criteria will form the unit of analysis. Data extracted from each study will be presented in table format (S2 Table). Information on parameters that describe safety and efficiency outcomes will be extracted and analysed. Outcome data will be reported as risk ratios and 95% confidence intervals (CI) for dichotomous outcomes or mean and standardized mean differences with 95% CI for continuous outcomes. The assessment of statistical heterogeneity will be examined using Chi2- and I2-statistics. PROSPERO registration number CRD42024532993.
Sedation with intranasal dexmedetomidine is not common practice in all countries, though the medicament has the potential to provide a child-friendly approach to sedation and premedication. Reviews on the area are conflicting, and new RCT studies have been published. Our systematic review aims to comprehensively assess intranasal paediatric sedation, focusing on dexmedetomidine and guiding clinicians in daily decision-making for optimal paediatric sedation.
镇静可确保儿童在手术过程中保持静止，并减轻焦虑。儿科镇静有多种药物治疗方案。然而，通常需要进行静脉置管，这会给儿童带来痛苦。在医疗程序中为儿童创造一个低压力环境至关重要。鼻内给予右美托咪定提供了一种有前景的替代方法，要么无需静脉置管，要么在必要进行置管时显著减轻压力和焦虑。我们旨在研究鼻内给予右美托咪定镇静儿童的安全性和有效性。
我们将系统检索MEDLINE（Ovid）、Embase（Ovid）、CINAHL（EBSCO）、CENTRAL、Clinicaltrials.gov和世界卫生组织国际临床试验注册平台。我们将纳入所有比较鼻内给予右美托咪定与其他镇静剂用于儿童术前用药或镇静的随机对照试验（RCT）。两名研究人员将使用Covidence独立筛选标题/摘要和全文文章以确定是否符合纳入标准。我们的主要结局是镇静成功率。符合纳入标准的RCT将构成分析单位。从每项研究中提取的数据将以表格形式呈现（表S2）。将提取并分析描述安全性和有效性结局的参数信息。结局数据将以风险比和95%置信区间（CI）报告二分结局，或以均值和标准化均值差及95%CI报告连续结局。将使用卡方检验和I²统计量检验统计异质性。PROSPERO注册号CRD42024532993。
尽管鼻内给予右美托咪定有潜力提供一种对儿童友好的镇静和术前用药方法，但在所有国家都并非常见做法。关于该领域的综述相互矛盾，并且已经发表了新的RCT研究。我们的系统综述旨在全面评估鼻内儿科镇静，重点关注右美托咪定，并为临床医生在日常最佳儿科镇静决策中提供指导。
