Opioid Laws and Pediatric Use

NCT ID: NCT04543227

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

980 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-10

Study Completion Date

2023-11-16

Brief Summary

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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

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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

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Burns Knee Injuries Opioid Use Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Retrospective Burn Injuries

Pediatric patients treated at a large academic pediatric medical center for burn injuries between August 2015 - August 2019.

No interventions assigned to this group

Retrospective Knee Arthroscopy

Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure between August 2015 - August 2019.

No interventions assigned to this group

Prospective Burn Injuries

Pediatric patients treated at a large academic pediatric medical center for burn injuries after July 2020.

Opioid Use 90-Days Post Treatment

Intervention Type BEHAVIORAL

Survey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain

Prospective Knee Arthroscopy

Pediatric patients treated at a large academic pediatric medical center for a knee arthroscopy procedure after July 2020.

Opioid Use 90-Days Post Treatment

Intervention Type BEHAVIORAL

Survey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio Department of Public Safety

UNKNOWN

Sponsor Role collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Henry Xiang

Professor and Center Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry Xiang, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 37972014 (View on PubMed)

Other Identifiers

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STUDY00001192

Identifier Type: -

Identifier Source: org_study_id

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