Monteiro Joana, Tanday Ajit, Ashley Paul F, Parekh Susan, Alamri Hamdan
UCL Eastman Dental Institute, Unit of Paediatric Dentistry, Department of Craniofacial Growth and Development, 256 Gray's Inn Road, London, UK, WC1X 8LD.
The University of Manchester, PhD student at School of Medical Sciences, Division of Dentistry, Manchester, UK.
Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD011024. doi: 10.1002/14651858.CD011024.pub2.
Delivery of pain-free dentistry is crucial for reducing fear and anxiety, completion of treatment, and increasing acceptance of future dental treatment in children. Local anaesthetic (LA) facilitates this pain-free approach but it remains challenging. A number of interventions to help children cope with delivery of LA have been described, with no consensus on the best method to increase its acceptance.
To evaluate the effects of methods for acceptance of LA in children and adolescents during dental treatment.
Cochrane Oral Health's Information Specialist searched the Cochrane Oral Health's Trials Register (to 24 May 2019); the Cochrane Central Register of Controlled Trials (CENTRAL; 2019 Issue 4) in the Cochrane Library (searched 24 May 2019); MEDLINE Ovid (1946 to 24 of May 2019); Embase Ovid (1980 to 24 May 2019); and Web of Science (1900 to 24 May 2019). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and World Health Organization International Clinical Trials Registry Platform were also searched to 24 May 2019. There were no restrictions on language or date of publications.
Parallel randomised controlled trials (RCTs) of interventions used to increase acceptance of dental LA in children and adolescents under the age of 18 years.
We used standard methodological procedures expected by Cochrane. We performed data extraction and assessment of risk of bias independently and in duplicate. We contacted authors for missing information. We assessed the certainty of the body of evidence using GRADE.
We included 26 trials with 2435 randomised participants aged between 2 and 16 years. Studies were carried out between 2002 and 2019 in dental clinics in the UK, USA, the Netherlands, Iran, India, France, Egypt, Saudi Arabia, Syria, Mexico, and Korea. Studies included equipment interventions (using several LA delivery devices for injection or audiovisual aids used immediately prior to or during LA delivery or both) and dentist interventions (psychological behaviour interventions delivered in advance of LA (video modelling), or immediately prior to or during delivery of LA or both (hypnosis, counter-stimulation). We judged one study to be at low risk and the rest at high risk of bias. Clinical heterogeneity of the included studies rendered it impossible to pool data into meta-analyses. None of the studies reported on our primary outcome of acceptance of LA. No studies reported on the following secondary outcomes: completion of dental treatment, successful LA/painless treatment, patient satisfaction, parent satisfaction, and adverse events. Audiovisual distraction compared to conventional treatment: the evidence was uncertain for the outcome pain-related behaviour during delivery of LA with a reduction in negative behaviour when 3D video glasses where used in the audiovisual distraction group (risk ratio (RR) 0.13, 95% confidence interval (CI) 0.03 to 0.50; 1 trial, 60 participants; very low-certainty evidence). The wand versus conventional treatment: the evidence was uncertain regarding the effect of the wand on pain-related behaviour during delivery of LA. Four studies reported a benefit in using the wand while the remaining studies results suggested no difference between the two methods of delivering LA (six trials, 704 participants; very low-certainty evidence). Counter-stimulation/distraction versus conventional treatment: the evidence was uncertain for the outcome pain experience during delivery of LA with children experiencing less pain when counter-stimulation was used (RR 0.12, 95% CI 0.04 to 0.34; 1 trial, 134 participants; very low-certainty evidence). Hypnosis versus conventional treatment: the evidence was uncertain for the outcome pain experience during delivery of LA with participants in the hypnosis group experiencing less pain (mean difference (MD) -1.79, 95% CI -3.01 to -0.57; 1 trial, 29 participants; very low-certainty evidence). Other comparisons considered included pre-cooling of the injection site, the wand versus Sleeper One, the use of a camouflage syringe, use of an electrical counter-stimulation device, and video modelling acclimatisation, and had a single study each. The findings from these other comparisons were insufficient to draw any affirmative conclusions about their effectiveness, and were considered to be very low-certainty evidence.
AUTHORS' CONCLUSIONS: We did not find sufficient evidence to draw firm conclusions as to the best interventions to increase acceptance of LA in children due to variation in methodology and nature/timing of outcome measures. We recommend further parallel RCTs, reported in line with the CONSORT Statement. Care should be taken when choosing outcome measures.
提供无痛牙科治疗对于减轻儿童的恐惧和焦虑、完成治疗以及提高其对未来牙科治疗的接受度至关重要。局部麻醉(LA)有助于实现这种无痛治疗方法,但仍然具有挑战性。已经描述了一些帮助儿童应对局部麻醉的干预措施,但对于提高其接受度的最佳方法尚未达成共识。
评估在牙科治疗期间提高儿童和青少年对局部麻醉接受度的方法的效果。
Cochrane口腔健康信息专家检索了Cochrane口腔健康试验注册库(截至2019年5月24日);Cochrane图书馆中的Cochrane对照试验中央注册库(CENTRAL;2019年第4期)(检索于2019年5月24日);MEDLINE Ovid(1946年至2019年5月24日);Embase Ovid(1980年至2019年5月24日);以及Web of Science(1900年至2019年5月24日)。还检索了美国国立卫生研究院正在进行的试验注册库(ClinicalTrials.gov)和世界卫生组织国际临床试验注册平台,截至2019年5月24日。对出版物的语言或日期没有限制。
用于提高18岁以下儿童和青少年对牙科局部麻醉接受度的干预措施的平行随机对照试验(RCT)。
我们采用了Cochrane预期的标准方法程序。我们独立且重复地进行了数据提取和偏倚风险评估。我们联系作者获取缺失信息。我们使用GRADE评估证据体的确定性。
我们纳入了26项试验,共2435名年龄在2至16岁之间的随机参与者。研究于2002年至2019年在英国、美国、荷兰、伊朗、印度、法国、埃及、沙特阿拉伯、叙利亚、墨西哥和韩国的牙科诊所进行。研究包括设备干预(使用多种局部麻醉注射设备或在局部麻醉注射前或期间使用视听辅助工具或两者兼用)和牙医干预(在局部麻醉前进行的心理行为干预(视频示范),或在局部麻醉注射前或期间或两者兼用(催眠、反刺激))。我们判定一项研究偏倚风险低,其余研究偏倚风险高。纳入研究的临床异质性使得无法将数据合并进行荟萃分析。没有一项研究报告我们关于局部麻醉接受度的主要结局。没有研究报告以下次要结局:牙科治疗的完成情况、成功的局部麻醉/无痛治疗、患者满意度、家长满意度和不良事件。与传统治疗相比的视听分心:关于局部麻醉注射期间与疼痛相关行为的结局,证据不确定,当视听分心组使用3D视频眼镜时,负面行为减少(风险比(RR)0.13,95%置信区间(CI)0.03至0.50;1项试验,60名参与者;极低确定性证据)。笔式注射器与传统治疗:关于笔式注射器对局部麻醉注射期间与疼痛相关行为的影响,证据不确定。四项研究报告使用笔式注射器有好处,而其余研究结果表明两种局部麻醉注射方法之间没有差异(六项试验,704名参与者;极低确定性证据)。反刺激/分心与传统治疗:关于局部麻醉注射期间疼痛体验的结局,证据不确定,使用反刺激时儿童疼痛减轻(RR 0.12,95%CI 0.04至0.34;1项试验,134名参与者;极低确定性证据)。催眠与传统治疗:关于局部麻醉注射期间疼痛体验的结局,证据不确定,催眠组参与者疼痛减轻(平均差(MD)-1.79,95%CI -3.01至-0.57;1项试验,29名参与者;极低确定性证据)。考虑的其他比较包括注射部位预冷、笔式注射器与Sleeper One、使用伪装注射器、使用电反刺激设备以及视频示范适应,每项都只有一项研究。这些其他比较的结果不足以就其有效性得出任何肯定结论,被认为是极低确定性证据。
由于方法学以及结局测量的性质/时间存在差异,我们没有找到足够的证据就提高儿童对局部麻醉接受度的最佳干预措施得出确凿结论。我们建议进一步进行符合CONSORT声明报告的平行随机对照试验。选择结局测量时应谨慎。