Pain ManagementNCT04059055
Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair
An observational study of Pain Management, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Over the past two decades, the misuse of prescription opioids has significantly increased. A recent systematic review reported as much as 67% to 92% of opioids dispensed on discharge post-surgery go unused. This culture of overprescribing is consistently observed across surgical specialties. Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- How many people
- 175 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Any child (0-18 years) who has undergone a supracondylar fracture repair at The Hospital for Sick Children.
Who may be able to join
- Patients with supracondylar fractures undergoing surgical wire placement or pinning that return to fracture clinic at three weeks for removal of pins/wires.
- Patients discharged on the weekday.
- Families filling a prescription for opioids at Shoppers Drug Mart at SickKids Hospital.
- Parent has strong command of the English language (i.e., no interpreter required).
Who cannot join
- Patients with a history of chronic pain.
- Patient used opioid medication within the previous 6 months.
- Patients who are discharged on the weekend (as participant emails will need to be entered into redcap the day of recruitment, for data collection to commence the next morning).
Trial locations and contacts
1 site in 1 country.
About this study
Over the past two decades, the misuse of prescription opioids has significantly increased. A recent systematic review reported as much as 67% to 92% of opioids dispensed on discharge post-surgery go unused. This culture of overprescribing is consistently observed across surgical specialties. Less frequently observed is the potential for opioid use and misuse in children and adolescents post-surgery. The research to date in this area has been poorly performed with heterogenous data collection, analysis and reporting, as well as large loss of patients to follow-up.
The investigators' previous prospective observational deception study identified three areas of concern:
- There is a culture of postoperative opioid over-prescribing at discharge as demonstrated by heterogenous opioid dosing and duration of treatments across practitioners for single procedures
- This overprescribing is in excess of patients' home-requirements and results in significant quantities of leftover opioids
- There is a culture of inappropriate storage and lack of safe disposal of prescribed opioids in the community
Read the detailed description
This study focuses on addressing and minimizing pediatric surgical over-prescribing. It aims to reduce the amount of opioids prescribed by focusing prescribers and families on regular use of simple non-opioid analgesics, as well as decreasing the amount of opioids prescribed and dispensed.
- Conditions
- Pain Management
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain medication use questionnaire
Recording of how many pain meds were used at home
Measured: 3 days following discharge from hospital
Secondary outcomes (1)
Amount of opioid returned
Recording of how much opioid was returned to the hospital
Measured: 3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Oct 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conor McDonnell, The Hospital for Sick Children
- Investigators
- Conor Mc Donnell, Principal investigator, Staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059055
- Sponsor's protocol ID
- 1000064960
- Status last verified
- Dec 2021
- First submitted
- 14 Aug 2019
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Unused Opioids in the Home Post Supracondylar Fracture Repair
- ClinicalTrials.gov ID
- NCT04059055
- Acronym / sponsor ID
- 1000064960
- Conditions
- Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the past two decades, the misuse of prescription opioids has significantly increased. A recent systematic review reported as much as 67% to 92% of opioids dispensed on discharge post-surgery go unused. This culture of overprescribing is consistently observed across surgical specialties. Less frequently observed is the potential for opioid use and misuse in children and adolescents post-surgery. The research to date in this area has been poorly performed with heterogenous data collection, analysis and reporting, as well as large loss of patients to follow-up.
The investigators' previous prospective observational deception study identified three areas of concern:
- There is a culture of postoperative opioid over-prescribing at discharge as demonstrated by heterogenous opioid dosing and duration of treatments across practitioners for single procedures
- This overprescribing is in excess of patients' home-requirements and results in significant quantities of leftover opioids
- There is a culture of inappropriate storage and lack of safe disposal of prescribed opioids in the community
Detailed description
This study focuses on addressing and minimizing pediatric surgical over-prescribing. It aims to reduce the amount of opioids prescribed by focusing prescribers and families on regular use of simple non-opioid analgesics, as well as decreasing the amount of opioids prescribed and dispensed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Any child (0-18 years) who has undergone a supracondylar fracture repair at The Hospital for Sick Children.
Key inclusion criteria (4 listed)
- Patients with supracondylar fractures undergoing surgical wire placement or pinning that return to fracture clinic at three weeks for removal of pins/wires.
- Patients discharged on the weekday.
- Families filling a prescription for opioids at Shoppers Drug Mart at SickKids Hospital.
- Parent has strong command of the English language (i.e., no interpreter required).
Key exclusion criteria (3 listed)
- Patients with a history of chronic pain.
- Patient used opioid medication within the previous 6 months.
- Patients who are discharged on the weekend (as participant emails will need to be entered into redcap the day of recruitment, for data collection to commence the next morning).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain medication use questionnaire
Time frame: 3 days following discharge from hospital
Recording of how many pain meds were used at home
1 secondary outcome
Amount of opioid returned
Time frame: 3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conor Mc Donnell principal investigator
Staff Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain medication use questionnaire (time frame: 3 days following discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.