Tapering opioids for trauma patients to reduce long-term opioid use

Not Applicable

Completed

• Conditions: Opioid dependence in trauma patients; Mental and Behavioural Disorders; Opioid dependence

• Registration Number: ISRCTN40263056
• Lead Sponsor: Trauma Association of Canada

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-17
• Study Completion: 2020-12-01
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Morphine equivalent dose (MED) per day at 12 weeks after the beginning of TOPP-Trauma.

Secondary Outcome Measures

Name	Time	Method
<br> 1. MED per day at 6 weeks after the beginning of TOPP-Trauma, since some study findings indicated that a great proportion of trauma do not use opioids beyond this period of time<br> 2. Pain intensity and pain interference with activities assessed using the Brief Pain Inventory at baseline and 6 and 12 weeks after the start of the intervention<br>