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Effect of Opioid Shortage on Drug Selection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099030
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease
Opioid Use, Unspecified

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 1668 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Effects of the Opioid Drug Shortages on Selection of Nonopioid Analgesics During Laparoscopic Cholecystectomy
Actual Study Start Date : April 5, 2019
Actual Primary Completion Date : December 13, 2019
Actual Study Completion Date : December 13, 2019

Group/Cohort
Opioid shortage
Patients undergoing laparoscopic cholecystectomy during time of Fentanyl drug shortage
Normal Opioid supply (no shortage)
Patients undergoing laparoscopic cholecystectomy during time of normal Fentanyl drug supply



Primary Outcome Measures :
  1. Total Fentanyl usage [ Time Frame: September 2016 to August 2017 ]
    Monthly average amount administered per case per kg

  2. Total Fentanyl usage [ Time Frame: September 2017 to May 2018 ]
    Monthly average amount administered per case per kg

  3. Total Fentanyl usage [ Time Frame: June 2018 to May 2019 ]
    Monthly average amount administered per case per kg


Secondary Outcome Measures :
  1. Nonopioid analgesia usage [ Time Frame: September 2016 to August 2017 ]
    Monthly average amount administered per case per kg

  2. Nonopioid analgesia usage [ Time Frame: September 2017 to May 2018 ]
    Monthly average amount administered per case per kg

  3. Nonopioid analgesia usage [ Time Frame: June 2018 to May 2019 ]
    Monthly average amount administered per case per kg

  4. Number of CPR incidents [ Time Frame: September 2016 to August 2017 ]
    post-operative complication

  5. Number of CPR incidents [ Time Frame: September 2017 to May 2018 ]
    post-operative complication

  6. Number of CPR incidents [ Time Frame: June 2018 to May 2019 ]
    post-operative complication

  7. Number of reintubation incidents [ Time Frame: September 2016 to August 2017 ]
    post-operative complication

  8. Number of reintubation incidents [ Time Frame: September 2017 to May 2018 ]
    post-operative complication

  9. Number of reintubation incidents [ Time Frame: June 2018 to May 2019 ]
    post-operative complication

  10. Number of incidents requiring administration of emergency drugs [ Time Frame: September 2016 to August 2017 ]
    post-operative complication

  11. Number of incidents requiring administration of emergency drugs [ Time Frame: September 2016 to May 2018 ]
    post-operative complication

  12. Number of incidents requiring administration of emergency drugs [ Time Frame: June 2018 to May 2019 ]
    post-operative complication

  13. Length of hospital stay [ Time Frame: September 2016 to August 2017 ]
  14. Length of hospital stay [ Time Frame: September 2016 to May 2018 ]
  15. Length of hospital stay [ Time Frame: June 2018 to May 2019 ]

Other Outcome Measures:
  1. Postoperative Pain Scores [ Time Frame: September 2016 to August 2017 ]
    Pain scores range from 0 to 10 with higher score denoting more pain

  2. Postoperative Pain Scores [ Time Frame: September 2017 to May 2018 ]
    Pain scores range from 0 to 10 with higher score denoting more pain

  3. Postoperative Pain Scores [ Time Frame: June 2018 to May 2019 ]
    Pain scores range from 0 to 10 with higher score denoting more pain

  4. Time Spent in Post-anesthesia Care Unit (PACU) [ Time Frame: September 2016 to August 2017 ]
  5. Time Spent in Post-anesthesia Care Unit (PACU) [ Time Frame: September 2017 to May 2018 ]
  6. Time Spent in Post-anesthesia Care Unit (PACU) [ Time Frame: June 2018 to May 2019 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing Laparoscopic Cholecystectomy at Wake Forest Baptist Medical Center General ORS
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099030


Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Scott Miller, MD Wake Forest University Health Sciences
Publications:
1. Durkin, M. (n.d.). IV drug shortages present challenges, opportunities. Retrieved March 6, 2019, from https://acphospitalist.org/archives/2018/09/iv-drug-shortages-present-challenges-opportunities.htm 2. Press Announcements > Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA's Center for Drug Evaluation and Research, on the agency's response to ongoing drug shortages for critical products. (n.d.). Retrieved March 6, 2019, from https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm611215.htm 3. 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. PubMed PMID: 30367645; PubMed Central PMCID: PMC6204001.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04099030    
Other Study ID Numbers: IRB00057062
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
drug shortage