CClinicalTrials.gg
CompletedNCT03959787Updated Oct 28, 2021

Surgical Patient Knowledge and Safe Use of Opioids

An interventional study of Educational in Opioid Use, sponsored by University Health Network, Toronto. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Opioids are commonly prescribed for surgical patients to treat moderate to severe pain after surgery. However, opioids can be associated with serious complications such as respiratory depression and death. Currently, it is not routine practice to provide standardized written materials to surgical patients about the risks of opioids and how to safely use opioids after surgery. Investigator has developed an educational pamphlet specifically for surgical patients to educate them about the safe use of opioids.

The objective of this study is to determine whether the pamphlet increases surgical patients' knowledge about the safe use, proper storage and disposal of opioids.

Read the detailed description

Participants presenting to the preoperative clinic will be recruited for this trial. After informed consent is obtained, patients will be randomized to one of 2 groups: 1) educational pamphlet and standard care, or 2) control group - standard care (no pamphlet) All patients will complete the opioid knowledge questionnaire to test baseline knowledge on opioids. If patient is randomized to the educational pamphlet and standard care, patient will receive the educational pamphlet and standard care. After the patient reviews the pamphlet, the patient will complete the questionnaire again. If the patient is randomized to the control group, the patient will receive the usual standard of care.

All patients will be contacted by telephone 15 days and 30 days after surgery to conduct the follow-up.

02

Conditions studied

  • Opioid Use
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

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

Inclusion criteria

  • All English speaking
  • Adult (≥18 yrs) surgical patients presenting to the Preoperative Clinic

Exclusion criteria

Exclusion Criteria:

  • Patients who are on opioids for chronic pain
  • Patients have taken opioids in the past 30 days
  • Patients who are unable to read and understand English
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Educational pamphlet and standard care

    patients randomized to the educational pamphlet arm will receive the educational pamphlet

    Other: Educational

  • No intervention
    control group - standard care

    Patients randomized to control arm, will receive the standard care.

Interventions

  • OtherEducational

    Educational pamphlet will be given to intervention group.

06

What researchers measure

Primary outcomes

  1. Change in knowledge

    Change in knowledge on safe opioid use questionnaire immediately post-education.

    Time frame: day 1

Secondary outcomes

  1. Knowledge retention

    Knowledge retention of safe opioid use questionnaire 15 days/30 days post-education. Proper disposal of unused opioids.

    Time frame: 15 and 30 days

07

Study locations

2 sites
  • Women's College Hospital
    Toronto, Ontario M5S 1B2, Canada
  • Toronto Western Hospital, University Health Network
    Toronto, Ontario M5T 2S8, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03959787
Lead sponsor
University Health Network, Toronto
Collaborators
Ontario Ministry of Health and Long Term Care
Responsible party
Jean Wong (Principal Investigator, University Health Network, Toronto) — Principal investigator
First posted
May 22, 2019
Start date
May 23, 2019
Primary completion
Apr 30, 2020
Completion
Sep 30, 2020
Last update
Oct 28, 2021

Study contacts

Jean Wong, MD
principal investigator · University Health Network, Toronto

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 Oct 2021. You cannot join it, but the record below documents what was studied.

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