BurnsNCT04543227
Opioid Laws and Pediatric Use
An observational study of Burns and Knee Injuries, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The legitimate need for opioid medications for acute pain management in pediatric trauma patients is recognized, however, the high dose and duration of opioid drugs prescribed by medical providers has been associated with an increased risk of opioid abuse and chronic use by patients. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Burns, Knee Injuries, Opioid Use
- What is being tested?
- Opioid Use 90-Days Post Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 980 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2020to 16 Nov 2023
- 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
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients (age 0-18 years) treated at our institution for either a burn injury or knee arthroscopy procedure and received an opioid prescription.
Who may be able to join
- pediatric patients age 0-18 years (inclusive)
- treated at our institution for either a burn injury or knee arthroscopy procedure
- received at least one opioid prescription
Who cannot join
- patients age 19 years and above
- patients who did not receive any opioid medications
- patients undergoing knee arthroscopy with simultaneous anterior cruciate ligament (ACL) reconstruction
- families unable to to communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: The Impact of Ohio's Opioid Prescriptions Law on Opioid Use and Outcomes in Pediatric Patients
The legitimate need for opioid medications for acute pain management in pediatric trauma patients is recognized, however, the high dose and duration of opioid drugs prescribed by medical providers has been associated with an increased risk of opioid abuse and chronic use by patients. The overarching goal of application is to assess opioid use and outcomes of pediatric patients treated for either burn injuries or knee arthroscopy procedures at a large academic pediatric medical center before and after Ohio opioid prescription rules for acute pain were implemented on August 21, 2017. Also, to evaluate patient use of opioids at 90-days post-treatment.
Read the detailed description
This study has a prospective and retrospective component. Phase 1 involves a retrospective chart review will be performed among pediatric patients undergoing burn care or knee arthroscopy at our institution to determine a whether there was a reduction in prescribed opioid medications following the 2017 Ohio opioid prescription law. A 24-month pre-law period (August 1st, 2015, to August 31st, 2017) and 24-month post-law period (September 1st, 2017, to August 31st 2019) will be compared. This phase will include 300 patients (n=150 burn, n=150 knee arthroscopy) evenly divided between the pre-law and post-law periods.
Phase 2 involves a prospective patient telephone survey 90 days after burn care or knee arthroscopy procedure to assess the association of opioid prescribing, consumption and amount of left-over medications, and pain control status after 90 days. This phase will include 100 patients (n=50 burn, n=50 knee arthroscopy) recruited via convenience sampling.
- Conditions
- Burns, Knee Injuries, Opioid Use, Pain
- Being tested
- Opioid Use 90-Days Post Treatment
- Keywords
- Burns, Knee Arthroscopy, Opioid, Pain, Chronic
- Medical subject headings
- Burns, Knee Injuries, Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Use 90-Days Post TreatmentBehavioural
Survey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Burn Injuries | Pediatric patients treated at a large academic pediatric medical center for burn injuries between August 2015 - August 2019. | |
| Retrospective Knee Arthroscopy | Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure between August 2015 - August 2019. | |
| Prospective Burn Injuries | Pediatric patients treated at a large academic pediatric medical center for burn injuries after July 2020. Receives: Behavioral: Opioid Use 90-Days Post Treatment | |
| Prospective Knee Arthroscopy | Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure after July 2020. Receives: Behavioral: Opioid Use 90-Days Post Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in opioid prescriptions
Change in opioid medications prescribed pre-law and post-law (reported in morphine equivalent doses)
Measured: 2 years before and 2 years after Ohio opioid law
Long-term opioid use
Patients using opioid medications 90-days post treatment
Measured: 90 days post treatment
Secondary outcomes (1)
Comparison of opioid medications usage
Comparison of opioid medications prescribed by injury type (burn and knee arthroscopy)
Measured: 2 years before and 2 years after Ohio opioid law
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start10 Sep 2020
- Primary completion30 Jun 2022
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio Department of Public Safety
- Responsible party
- Principal investigator, Henry Xiang, Nationwide Children's Hospital
- Investigators
- Henry Xiang, MD, MPH, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543227
- Sponsor's protocol ID
- STUDY00001192
- Status last verified
- Apr 2024
- First submitted
- 2 Sep 2020
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armstrong M, Groner JI, Samora J, Olbrecht VA, Tram NK, Noffsinger D, Boyer EW, Xiang H. Impact of opioid law on prescriptions and satisfaction of pediatric burn and orthopedic patients: An epidemiologic study. PLoS One. 2023 Nov 16;18(11):e0294279. doi: 10.1371/journal.pone.0294279. eCollection 2023.
PubMed 37972014
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ohio's Opioid Prescriptions Law on Opioid Use and Outcomes in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04543227
- Acronym / sponsor ID
- STUDY00001192
- Conditions
- Burns, Knee Injuries, Opioid Use, Pain
- Keywords
- Burns, Knee Arthroscopy, Opioid, Pain, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Ohio Department of Public Safety
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 10 Sep 2020 (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.
The legitimate need for opioid medications for acute pain management in pediatric trauma patients is recognized, however, the high dose and duration of opioid drugs prescribed by medical providers has been associated with an increased risk of opioid abuse and chronic use by patients. The overarching goal of application is to assess opioid use and outcomes of pediatric patients treated for either burn injuries or knee arthroscopy procedures at a large academic pediatric medical center before and after Ohio opioid prescription rules for acute pain were implemented on August 21, 2017. Also, to evaluate patient use of opioids at 90-days post-treatment.
Detailed description
This study has a prospective and retrospective component. Phase 1 involves a retrospective chart review will be performed among pediatric patients undergoing burn care or knee arthroscopy at our institution to determine a whether there was a reduction in prescribed opioid medications following the 2017 Ohio opioid prescription law. A 24-month pre-law period (August 1st, 2015, to August 31st, 2017) and 24-month post-law period (September 1st, 2017, to August 31st 2019) will be compared. This phase will include 300 patients (n=150 burn, n=150 knee arthroscopy) evenly divided between the pre-law and post-law periods.
Phase 2 involves a prospective patient telephone survey 90 days after burn care or knee arthroscopy procedure to assess the association of opioid prescribing, consumption and amount of left-over medications, and pain control status after 90 days. This phase will include 100 patients (n=50 burn, n=50 knee arthroscopy) recruited via convenience sampling.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Retrospective Burn Injuries | – | –Pediatric patients treated at a large academic pediatric medical center for burn injuries between August 2015 - August 2019. |
| Retrospective Knee Arthroscopy | – | –Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure between August 2015 - August 2019. |
| Prospective Burn Injuries | – | Behavioral: Opioid Use 90-Days Post TreatmentPediatric patients treated at a large academic pediatric medical center for burn injuries after July 2020. |
| Prospective Knee Arthroscopy | – | Behavioral: Opioid Use 90-Days Post TreatmentPediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure after July 2020. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients (age 0-18 years) treated at our institution for either a burn injury or knee arthroscopy procedure and received an opioid prescription.
Key inclusion criteria (3 listed)
- pediatric patients age 0-18 years (inclusive)
- treated at our institution for either a burn injury or knee arthroscopy procedure
- received at least one opioid prescription
Key exclusion criteria (4 listed)
- patients age 19 years and above
- patients who did not receive any opioid medications
- patients undergoing knee arthroscopy with simultaneous anterior cruciate ligament (ACL) reconstruction
- families unable to to communicate in English
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 |
|---|---|---|
| Opioid Use 90-Days Post TreatmentSurvey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain | Behavioural | Prospective Burn Injuries, Prospective Knee Arthroscopy |
Primary outcome
Change in opioid prescriptions
Time frame: 2 years before and 2 years after Ohio opioid law
Change in opioid medications prescribed pre-law and post-law (reported in morphine equivalent doses)
Long-term opioid use
Time frame: 90 days post treatment
Patients using opioid medications 90-days post treatment
1 secondary outcome
Comparison of opioid medications usage
Time frame: 2 years before and 2 years after Ohio opioid law
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 30 Apr 2024.
- Results publication: PubMed 37972014Armstrong M, Groner JI, Samora J, Olbrecht VA, Tram NK, Noffsinger D, Boyer EW, Xiang H. Impact of opioid law on prescriptions and satisfaction of pediatric burn and orthopedic patients: An epidemiologic study. PLoS One. 2023 Nov 16;18(11):e0294279. doi: 10.1371/journal.pone.0294279. eCollection 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.
Henry Xiang, MD, MPH, PhD principal investigator
Nationwide Children's Hospital
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 Burns and Knee Injuries, run by Nationwide Children's Hospital at 1 site in United States.
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 3 inclusion and 4 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 30 Apr 2024. 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 United States. 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?
Change in opioid prescriptions (time frame: 2 years before and 2 years after Ohio opioid law). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04543227, which also lists 1 linked publication.
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 30 Apr 2024.