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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03959787
Other study ID # Version 15-April-2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 23, 2019
Est. completion date September 30, 2020

Study information

Verified date October 2021
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All English speaking - Adult (=18 yrs) surgical patients presenting to the Preoperative Clinic 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational
Educational pamphlet will be given to intervention group.

Locations

Country Name City State
Canada Toronto Western Hospital, University Health Network Toronto Ontario
Canada Women's College Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University Health Network, Toronto Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in knowledge Change in knowledge on safe opioid use questionnaire immediately post-education. day 1
Secondary Knowledge retention Knowledge retention of safe opioid use questionnaire 15 days/30 days post-education. Proper disposal of unused opioids. 15 and 30 days
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