Tapering Opioids Prescription Program for Trauma patients at high risk of chronic consumption (TOPP-Trauma): A pilot randomized controlled trial

Trauma Association of Canada0 个研究点目标入组 50 人开始时间: 2018年6月17日最近更新: 2022年2月1日

适应症

试验速览

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31110776 protocol (added 22/05/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34479822/ (added 19/01/2022)

•1. Aged 18 years and over
•2. Able to read and speak French or English
•3. =2 doses/day of opioids during the 3 previous days
•4. At least one risk factor for chronic consumption. The risks factors for chronic consumption are:
•4.1. Annual income =$40,000
•4.2. Injury Severity Score (ISS) =12
•4.3. Pre-injury use of opioids or substance abuse (Alcohol, Smoking and Substance Involvement Screening Test–version 3.0 =11 for alcohol and =4 for other substance)
•4.4. Anxiety or depression symptoms (scores =11 on the Hospital Anxiety and Depression Scale)
•4.5. Pain catastrophizing score =20 on the Pain Catastrophizing Scale
•4.6. Pain self-efficacy score <17 on the Pain Self-Efficacy Questionnaire
•5. Discharged directly from hospital to home

•Cognitive impairment (i.e. moderate-severe traumatic brain injury (TBI) – Glasgow Coma Scale score <13/15, dementia and severe psychiatric disorder) affecting the capacity to participate in the study. In some equivocal situations, where the cognitive function improved during hospitalization, the neurospychologist will provide an evaluation stipulating that patients with moderate TBI can participate in this study.

发起方

Trauma Association of Canada