An observational study in Burns, Knee Injuries and Opioid Use, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Nationwide Children's Hospital · Observational
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.
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.
249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.
This study's enrollment of 980 is above the median of 90 across 79 observational studies indexed under Knee Injuries.
Browse Knee Injuries studies →Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pediatric patients (age 0-18 years) treated at our institution for either a burn injury or knee arthroscopy procedure and received an opioid prescription.
Exclusion Criteria:
Pediatric patients treated at a large academic pediatric medical center for burn injuries between August 2015 - August 2019.
Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure between August 2015 - August 2019.
Pediatric patients treated at a large academic pediatric medical center for burn injuries after July 2020.
Behavioral: Opioid Use 90-Days Post Treatment
Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure after July 2020.
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
Change in opioid prescriptions
Change in opioid medications prescribed pre-law and post-law (reported in morphine equivalent doses)
Time frame: 2 years before and 2 years after Ohio opioid law
Long-term opioid use
Patients using opioid medications 90-days post treatment
Time frame: 90 days post treatment
Comparison of opioid medications usage
Comparison of opioid medications prescribed by injury type (burn and knee arthroscopy)
Time frame: 2 years before and 2 years after Ohio opioid law
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Nationwide Children's Hospital