Morton Leesa, Siu Amanda Tsan Yue, Fowler Samuel, Zhou Chen, Nixon Christopher, Campbell Doug
Department of Anaesthesia, Canterbury District Health Board, 2 Riccarton Avenue, Christchurch Central, Christchurch, 8011 New Zealand.
Department of Anaesthesia, Counties Manukau District Health Board, 100 Hospital Road, Otahuhu, Auckland 2025 New Zealand.
Pilot Feasibility Stud. 2020 Jun 24;6:89. doi: 10.1186/s40814-020-00630-0. eCollection 2020.
Dry mouth is a common perioperative patient complaint. There are a number of treatments used for dry mouth in other settings which are effective. None have been tested previously in the perioperative setting. Interventions to Manage Dry mouth (IM DRY) compared the effect of water and a saliva substitute on mouth dryness. The primary objective was to demonstrate the feasibility of conducting a large randomised controlled trial and secondary scientific aims were to assess treatment potential efficacy.
Single blind, pilot randomised controlled trial (RCT) of 101 pre-operative elective surgical patients who were randomised to water or saliva substitute (Biotene oral rinse, GlaxoSmithKline, Australia) at a tertiary, university hospital. Dry mouth was assessed by 100 mm visual analogue scale (VAS) and 5-point Likert score.
One hundred participants completed follow-up and comprised the analysis dataset. All feasibility outcomes were achieved (recruitment rate > 5 participants a week, >95% completeness of the dataset, study protocol acceptability to staff, acceptability to participants > 66% and adherence to time limits within the protocol). Mean recruitment rate was 6 participants per week. These data were 99% complete. There were no adverse side effects or complications noted. There were no concerns raised by staff regarding acceptability. Overall, there was a mean of 30 min (± SD 5 min) between delivery of the intervention and the assessment, 30 min being the target time. The difference in VAS post intervention was - 11.2 mm (95% CI - 17.3 to - 5.1 mm) for water and - 12.7 mm (95% CI - 18.7 to - 6.7 mm) for saliva substitute. The proportion of patients who had improved dry mouth increased from 52% for water to 62% for saliva substitute.
IM DRY successfully achieved its primary feasibility aims: recruitment rate, completeness of these, acceptability and protocol adherence. Saliva substitutes, used in the perioperative management of dry mouth, may be a simple, inexpensive, and low risk solution to help alleviate this common complaint. A large randomised controlled trial is feasible and is currently recruiting (ANZCTR 12619000132145).
Northern A New Zealand Health and Disability Ethics Committee (reference 17/NTA/152). Australian New Zealand Clinical Trials Registry (Number: 12618001270202). Registered retrospectively 18 October 2018.
口干是围手术期患者常见的主诉。在其他情况下有多种用于治疗口干的方法，且效果显著。但此前尚无在围手术期进行过测试的方法。管理口干干预措施（IM DRY）比较了水和唾液替代品对口干的影响。主要目的是证明开展一项大型随机对照试验的可行性，次要科学目标是评估治疗的潜在疗效。
在一所大学三级医院对101例择期手术的术前患者进行单盲、试点随机对照试验（RCT），这些患者被随机分为接受水或唾液替代品（比奥泉口腔护理液，葛兰素史克，澳大利亚）治疗组。通过100毫米视觉模拟量表（VAS）和5分制李克特量表评估口干情况。
100名参与者完成了随访并纳入分析数据集。所有可行性指标均达成（招募率>每周5名参与者，数据集完整性>95%，工作人员对研究方案的可接受性，参与者的可接受性>66%以及遵守方案中的时间限制）。平均招募率为每周6名参与者。这些数据的完整性为99%。未观察到不良副作用或并发症。工作人员未对可接受性提出任何担忧。总体而言，干预措施实施与评估之间的平均时间为30分钟（±标准差5分钟），目标时间为30分钟。干预后水组的VAS差异为-11.2毫米（95%置信区间-17.3至-5.1毫米），唾液替代品组为-12.7毫米（95%置信区间-18.7至-6.7毫米）。口干情况有所改善的患者比例从水组的52%增至唾液替代品组的62%。
IM DRY成功实现了其主要可行性目标：招募率、数据集完整性、可接受性和方案依从性。在围手术期口干管理中使用唾液替代品可能是一种简单、廉价且低风险的解决方案，有助于缓解这一常见主诉。开展一项大型随机对照试验是可行的，目前正在招募患者（澳大利亚新西兰临床试验注册中心编号：12619000132145）。
新西兰北部健康与残疾伦理委员会（编号17/NTA/152）。澳大利亚新西兰临床试验注册中心（编号：12618001270202）。于2018年10月18日追溯注册。
