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CompletedNCT07049796OPI-HOMEUpdated Jul 3, 2025

Impact of a Pharmaceutical Interview at the Initiation of Opioid Treatment for Acute Non-cancer Pain

An observational study in Interviews, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by University Hospital, Rouen · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

In adult emergency departments, the number of admissions for adverse effects related to opioid use is constantly increasing. However, the massive flow of patients, lack of time, and rapid rotation of physicians in this department do not favor the transmission of in-depth information on the proper use of these therapies to the patient. In addition, this therapeutic class tends to worry patients. Public authorities as well as the medical profession are concerned about the potential adverse effects of morphine, but also the potential misuse, or even overdose, which can be fatal for the patient. Interventions by the community pharmacist in the fight against this misuse seem interesting, but an intervention upstream of potential problems of proper use seems even more relevant to us. Recent studies have shown the strong interest of the pharmacist in a multidisciplinary team on pain and opioids, both at the local level with studies conducted at the Rouen University Hospital by C. LATTARD et al. in rheumatology and E.BARAT et al. in outpatient surgery. It also appears that knowledge on the subject is satisfactory. Work conducted by Winstanley et al. shows that the intervention of a pharmacist in the emergency department seems relevant in terms of patient knowledge and satisfaction, and entirely feasible.

Read the detailed description

This study aims to measure the clinical impact of a hospital pharmacist when initiating opioid treatment for acute non-cancer pain in the Short Stay Hospitalization Units (UHCD) and Downstream Hospitalization Units (UHA) of the adult emergency department at Rouen University Hospital.

Pharmacy interviews will be offered to patients meeting the inclusion criteria. These 15- to 30-minute interviews will aim to present the tools implemented by the Rouen University Hospital pharmacy team. Several topics will be discussed, including: treatment optimization, potential adverse effects and what to do if they occur, the differences between immediate-release (IR) and extended-release (LP) forms, what to do if a dose is missed, the risks of overdose and addiction, and storage methods.

The objective of this project is, firstly, to improve patient satisfaction with their care and, secondly, to better understand the treatment, thus enabling more optimal use.

02

Conditions studied

  • Interviews

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Keywords

  • Impact and feasibility of a pharmaceutical interview
  • opioid treatment
03

In context

Tooth, Impacted

122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.

This study's enrollment of 100 is close to the median of 105 across 31 observational studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive patients over 18 years of age with opioid analgesic treatment upon discharge from hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patient (>18 years old)
  • Patient admitted to the following departments: Downstream Hospitalization Unit (UHA) and Short-Term Hospitalization Unit (UHCD)
  • Independent patient or assisted by close family (who can receive information with the patient)
  • Initiation of opioid treatment for acute non-cancer pain during their stay in the Emergency Department, UHA, or UHCD or shortly before (\<7 days)
  • Patient speaks French
  • Presence of the clinical pharmacist in the relevant departments

Exclusion criteria

Exclusion Criteria:

  • Patient with drug addiction
  • Patient under guardianship/guardianship
  • Patient transferred to rheumatology
  • Patient already on opioid treatment for ≥ 7 days
  • Patient refuses
  • Patient assisted by a nurse at home or a caregiver not present during hospitalization
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Target follow-up
9 Days
Patient registry
Yes

Groups and cohorts

  • Prospective cohort including patients with opioid analgesic treatment upon discharge from hospital
06

What researchers measure

Primary outcomes

  1. Evaluation of satisfaction with a pharmaceutical interview for acute pain

    To assess satisfaction with pharmaceutical care for acute non-cancer pain in short-term hospitalization units (UHCD) and emergency downstream hospitalization units (UHA) during a telephone call to the patient 7 days after discharge from hospital. This satisfaction will be quantified as a percentage from 0 to 100%.

    Time frame: Day 7

Secondary outcomes

  1. Evaluation of the relevance and effectiveness of pharmaceutical maintenance against pain

    Patient satisfaction with pharmaceutical pain management on day 3 will be assessed during a telephone call to the patient 3 days after discharge from hospital. This satisfaction will be quantified as a percentage from 0 to 100%.

    Time frame: Day 3

  2. Evaluation of the relevance and effectiveness of pharmaceutical maintenance against pain

    The average pain assessment on admission, discharge, day 3 and day 7 will be evaluated using a numerical scale from 0 to 10.

    Time frame: Day 3 and Day 7

07

Study locations

1 site
  • University Rouen Hospital
    Rouen, 76031, France
08

References and documents

Individual participant data

Plan to share: No — The data provided will be the property of the sponsor and will be used solely for its own research activities.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2021 to primary completion in Nov 2024, 37 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2025
First posted
Jul 3, 2025
StartActual
Oct 12, 2021
Primary completionActual
Nov 30, 2024
CompletionActual
May 31, 2025
Last update
Jul 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07049796
Responsible party
Sponsor
First posted
Jul 3, 2025
Start date
Oct 12, 2021
Primary completion
Nov 30, 2024
Completion
May 31, 2025
Last update
Jul 3, 2025

Study contacts

Johanna JR RAYMOND, Doctor
study director · University Rouen Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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