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Recruiting

NCT Number: NCT05905146

Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain.

The aim of this study is to evaluate whether patients who benefit from a personalized pharmaceutical plan (PPP) during their hospitalization, allowing them to be informed and sensitized, are treated for a shorter period of time with strong opioids with a reduced risk of dependence compared to a management according to the usual modalities in the rheumatology services concerned.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Lille, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient hospitalized in the rheumatology department
  • Patient with acute pain in the context of a non-cancerous, non-traumatic, high-energy musculoskeletal pathology
  • Patient for whom a prescription of strong opioid derivatives is initiated in rheumatology or patient for whom a prescription of strong opioid derivatives is maintained in rheumatology if the initial prescription has a maximum duration of 30 consecutive days prior to inclusion

Exclusion criteria

  • Patient with cancer or fibromyalgia already diagnosed at inclusion
  • Patient with poor French language skills
  • Taking a strong opioid treatment for more than 30 consecutive days prior to inclusion
  • Person judged by the prescriber or pharmacist as not autonomous for the management of strong opioid treatment
  • Patient already included in the study

Treatment and study plan

personalized pharmaceutical plan

Other

multi-professional intervention around strong opioid treatment with targeted pharmaceutical interview

Primary outcomes

  1. total duration of treatment in days with strong opioids from day of inclusion

    Time frame: 6 months

Secondary outcomes

  1. number of patients exceeding the optimal duration of treatment with strong opioids defined by the SFETD learned society (French Society for the Study and Treatment of Pain) (3 months)

    Time frame: 3 months

  2. pain assessment (numerical scale) at first patient call after stopping strong opioids

    Time frame: 6 months

  3. number of patients exceeding the optimal duration of treatment with strong opioids defined by the CLUD (Pain Control Committee) of Rouen University Hospital (28 days)

    Time frame: 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Armelle GUIDOTTI

CONTACT

[email protected]

+3323288 ext. 8265

Catherine CHENAILLER

CONTACT

[email protected]

+3323288 ext. 82.07

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Impact of a Personalized Medication Plan on Duration of Treatment With Potent Opioids in Acute Non-cancer Musculoskeletal Pain. Multicenter, Randomized, Controlled Study

Acronym: PPPCARE II

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.