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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40263056
Enrollment
60
Registered
2018-06-17
Start date
2018-06-15
Completion date
Unknown
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid dependence in trauma patients Mental and Behavioural Disorders Opioid dependence

Interventions

Two groups will be studied in parallel and followed according to the study time points. In addition to usual care, the control group will receive a pamphlet, while the experimental group will receive
more specifically components, activities, dosages, and delivery modes. The TOPP-Trauma combines a 20-minute teaching session to be provided the week prior to hospital discharge and a maximum of six 15

Sponsors

Trauma Association of Canada
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Morphine equivalent dose (MED) per day at 12 weeks after the beginning of TOPP-Trauma.

Secondary

MeasureTime frame
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 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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026