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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04543227
Other study ID # STUDY00001192
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2020
Est. completion date November 16, 2023

Study information

Verified date April 2024
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 980
Est. completion date November 16, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Opioid Use 90-Days Post Treatment
Survey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Nationwide Children's Hospital Ohio Department of Public Safety

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in opioid prescriptions Change in opioid medications prescribed pre-law and post-law (reported in morphine equivalent doses) 2 years before and 2 years after Ohio opioid law
Primary Long-term opioid use Patients using opioid medications 90-days post treatment 90 days post treatment
Secondary Comparison of opioid medications usage Comparison of opioid medications prescribed by injury type (burn and knee arthroscopy) 2 years before and 2 years after Ohio opioid law
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