Effect of Opioid Shortage on Drug Selection

NCT ID: NCT04099030

Last Updated: 2020-04-16

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

1668 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-05

Study Completion Date

2019-12-13

Brief Summary

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This study will look at the effects of fentanyl shortage in laparoscopic cholecystectomy cases. The opioid shortage, specifically hydromorphone and fentanyl, caused a decrease in administration of opioid analgesia for laparoscopic cholecystectomy intraoperatively.

Detailed Description

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The goal of this study is to look at the clinical impact of the drug shortage of intravenous (IV) opioids from 2016 to 2018. IV opioids are used in the hospital setting ranging from the Emergency Department to the Intensive Care Unit (ICU) to the Operating room. This study will look at the usage of IV opioids in the operating room setting and determine how practice has change in the setting of drug shortage. The study team hypothesizes that the average monthly consumption of fentanyl and hydrophone would have been decreased for laparoscopic cholecystectomy intraoperatively during the opioid shortage period as compared to before the shortage period.

Conditions

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Opioid Use, Unspecified

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Opioid shortage

Patients undergoing laparoscopic cholecystectomy during time of Fentanyl drug shortage

No interventions assigned to this group

Normal Opioid supply (no shortage)

Patients undergoing laparoscopic cholecystectomy during time of normal Fentanyl drug supply

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All Genders
* History of laparoscopic cholecystectomy
* American Society of Anesthesiologist classification (ASA) 1-4 emergent and Non emergent
* Adult \>18 years old
* Wake Forest Baptist Medical Center Main Operating rooms

Exclusion Criteria

* Regional Anesthetic
* ASA 5 and 6
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Klaus DA, de Bettignies AM, Seemann R, Krenn CG, Roth GA. Impact of a remifentanil supply shortage on mechanical ventilation in a tertiary care hospital: a retrospective comparison. Crit Care. 2018 Oct 26;22(1):267. doi: 10.1186/s13054-018-2198-3.

Reference Type BACKGROUND
PMID: 30367645 (View on PubMed)

Other Identifiers

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IRB00057062

Identifier Type: -

Identifier Source: org_study_id

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