Helen and Douglas House Hospice, Oxford, UK.
Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.
BMJ Support Palliat Care. 2024 Jan 8;13(e3):e1019-e1028. doi: 10.1136/bmjspcare-2021-003278.
No randomised controlled trials have been conducted for breakthrough pain in paediatric palliative care and there are currently no standardised outcome measures. The DIPPER study aims to establish the feasibility of conducting a prospective randomised controlled trial comparing oral and transmucosal administration of opioids for breakthrough pain. The aim of the current study was to achieve consensus on design aspects for a small-scale prospective study to inform a future randomised controlled trial of oral morphine, the current first-line treatment, versus transmucosal diamorphine.
The nominal group technique was used to achieve consensus on best practice for mode of administration, dose regimen and a range of suitable pain intensity outcome measures for transmucosal diamorphine in children and young people with breakthrough pain. An expert panel of ten clinicians in paediatric palliative care and three parent representatives participated. Consensus was achieved when agreement was reached and no further comments from participants were forthcoming.
The panel favoured the buccal route of administration, with dosing according to the recommendations in the Association for Paediatric Palliative Medicine formulary (fifth Edition, 2020). The verbal Numerical Rating Scale was selected to measure pain in children 8 years old and older, the Faces Pain Scale-Revised for children between 4 and 8 years old, and Face, Legs, Activity, Cry and Consolability (FLACC)/FLACC-Revised as the observational tools.
The nominal group technique allowed consensus to be reached for a small-scale, prospective, cohort study and provided information to inform the design of a randomised controlled trial.
儿科姑息治疗中尚无突破性疼痛的随机对照试验,也没有标准化的结局测量指标。DIPPER 研究旨在确定进行前瞻性随机对照试验的可行性,比较口服和经黏膜给予阿片类药物治疗突破性疼痛。本研究旨在就小规模前瞻性研究的设计方面达成共识,为未来口服吗啡(目前的一线治疗药物)与经黏膜给予二吗啡的随机对照试验提供信息。
采用名义群体技术就经黏膜给予二吗啡治疗儿童和青少年突破性疼痛的最佳给药方式、剂量方案以及一系列合适的疼痛强度结局测量指标达成共识。一个由 10 名儿科姑息治疗临床医生和 3 名家长代表组成的专家小组参与了该研究。当参与者达成一致且没有进一步意见时,即达成共识。
专家组倾向于选择颊黏膜途径给药,剂量根据儿科姑息医学配方(第五版,2020 年)的建议。口头数字评分量表用于测量 8 岁及以上儿童的疼痛,修订面部疼痛评分量表用于 4 至 8 岁儿童,面部、腿部、活动、哭泣和安抚(FLACC)/FLACC 修订版用于观察工具。
名义群体技术使小型前瞻性队列研究达成了共识,并为随机对照试验的设计提供了信息。