Pain, PostoperativeNCT05372133
Split Scripts for Pediatric Supracondylar Fracture Repairs
A study testing Morphine in people with Pain, Postoperative, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study is designed to test the hypothesis that increased electronic order-set compliance and focused education will decrease the amount of unconsumed opioid entering and remaining in the home after pediatric supracondylar fracture repair The proposed study will address the hypothesis with the following objectives… Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteCanada
- Study dates
- 11 Aug 2022to 18 Aug 2023
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with Type II or Type III supracondylar fractures undergoing surgical wire placement or pinning that return to fracture clinic at three weeks for removal of pins/wires.
Who cannot join
- Patients who are not prescribed morphine following a supracondylar fracture repair surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 4 Split Script Study)
This study is designed to test the hypothesis that increased electronic order-set compliance and focused education will decrease the amount of unconsumed opioid entering and remaining in the home after pediatric supracondylar fracture repair
The proposed study will address the hypothesis with the following objectives:
- investigators will increase compliance with previously implemented standardized precision-based electronic discharge order sets;
- investigators will introduce part-fill opioid prescriptions for supracondylar fracture repairs;
- investigators will increase parental compliance with home administration of simple (non-opioid) analgesics;
- investigators will decrease opioid amount remaining in the home pre and post 3-week follow up.
Read the detailed description
Canada has one of the highest opioid prescribing rates in the world (United Nations, 2018). In 2017, Health Quality Ontario published a major report that identified the number of opioid prescriptions following surgery were second only to those following dentist office visits. As a result, Health Quality Ontario made the reduction of opioid prescribing ('Cut the Count)' their number one provincial healthcare priority of 2019.
To date, investigators have decreased MME amount of opioid entering the home post-supracondylar fracture repair at approximately 10 MME per patient and increased the rate of return of unused drug by 10 MME per patient. The Hospital for Sick Children alone performs some 200 such surgeries per year, representing 4,000 mg of morphine (four grams) that the community is no longer exposed to. This is only one surgery type in one hospital; expansion of our methodology to other surgeries (currently expanding to dental and cleft palates) and other institutions will dramatically decrease unintentional but iatrogenic home exposure of children and families to unwarranted and dangerous drugs.
This latest study aims to address all three steps outlined in the 2020-2021 Health Quality Ontario surgical mandate for children discharged from The Hospital for Sick Children after supracondylar fracture repair.
- Conditions
- Pain, Postoperative
- Being tested
- Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Opioid
Children will be provided with morphine for at-home pain management following supracondylar fracture repair
| Study group | Role | What they receive |
|---|---|---|
| Split Script | Experimental | Participants will receive four doses initially, with opportunity to obtain four additional doses if required Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023
Recording of how much morphine (mgs or doses) was used at home following supracondylar fracture repair surgery
Measured: 3 days following discharge from hospital
Secondary outcomes (3)
Compliance with orders for home use of acetaminophen and ibuprofen per SCF patient between July 2022 and October 2023
Recording of whether Tylenol and Advil were used at-home following supracondylar fracture repair surgery
Measured: 3 days following discharge from hospital
Amount of morphine milligram equivalents (MME) returned to pharmacy per SCF patient between July 2022 and October 2023
Recording of how much morphine was returned to the hospital pharmacy
Measured: 3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
Healthcare provider compliance to discharge order set
Recording of how often healthcare providers deviate from the standardized electronic discharge order set
Measured: Up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start11 Aug 2022
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372133
- Sponsor's protocol ID
- 1000079222
- Status last verified
- Nov 2023
- First submitted
- 15 Feb 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 4 Split Script Study)
- ClinicalTrials.gov ID
- NCT05372133
- Acronym / sponsor ID
- 1000079222
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 12 May 2022 (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.
This study is designed to test the hypothesis that increased electronic order-set compliance and focused education will decrease the amount of unconsumed opioid entering and remaining in the home after pediatric supracondylar fracture repair
The proposed study will address the hypothesis with the following objectives:
- investigators will increase compliance with previously implemented standardized precision-based electronic discharge order sets;
- investigators will introduce part-fill opioid prescriptions for supracondylar fracture repairs;
- investigators will increase parental compliance with home administration of simple (non-opioid) analgesics;
- investigators will decrease opioid amount remaining in the home pre and post 3-week follow up.
Detailed description
Canada has one of the highest opioid prescribing rates in the world (United Nations, 2018). In 2017, Health Quality Ontario published a major report that identified the number of opioid prescriptions following surgery were second only to those following dentist office visits. As a result, Health Quality Ontario made the reduction of opioid prescribing ('Cut the Count)' their number one provincial healthcare priority of 2019.
To date, investigators have decreased MME amount of opioid entering the home post-supracondylar fracture repair at approximately 10 MME per patient and increased the rate of return of unused drug by 10 MME per patient. The Hospital for Sick Children alone performs some 200 such surgeries per year, representing 4,000 mg of morphine (four grams) that the community is no longer exposed to. This is only one surgery type in one hospital; expansion of our methodology to other surgeries (currently expanding to dental and cleft palates) and other institutions will dramatically decrease unintentional but iatrogenic home exposure of children and families to unwarranted and dangerous drugs.
This latest study aims to address all three steps outlined in the 2020-2021 Health Quality Ontario surgical mandate for children discharged from The Hospital for Sick Children after supracondylar fracture repair.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Split Script | Experimental | Drug: MorphineParticipants will receive four doses initially, with opportunity to obtain four additional doses if required |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with Type II or Type III supracondylar fractures undergoing surgical wire placement or pinning that return to fracture clinic at three weeks for removal of pins/wires.
Key exclusion criteria (1 listed)
- Patients who are not prescribed morphine following a supracondylar fracture repair surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineAlso: OpioidChildren will be provided with morphine for at-home pain management following supracondylar fracture repair | Drug | Split Script |
Primary outcome
Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023
Time frame: 3 days following discharge from hospital
Recording of how much morphine (mgs or doses) was used at home following supracondylar fracture repair surgery
3 secondary outcomes
Compliance with orders for home use of acetaminophen and ibuprofen per SCF patient between July 2022 and October 2023
Time frame: 3 days following discharge from hospital
Amount of morphine milligram equivalents (MME) returned to pharmacy per SCF patient between July 2022 and October 2023
Time frame: 3 weeks following discharge (aligns with pin/wire removal at fracture clinic)
Healthcare provider compliance to discharge order set
Time frame: Up to 100 weeks
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 21 Nov 2023.
- Individual participant dataSharing planned: No
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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
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine in people with Pain, Postoperative, 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 1 inclusion and 1 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 21 Nov 2023. 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?
Amount of morphine milligram equivalents (MME) used at home per SCF patient between July 2022 and October 2023 (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 21 Nov 2023.