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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04099030
Other study ID # IRB00057062
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 5, 2019
Est. completion date December 13, 2019

Study information

Verified date September 2019
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1668
Est. completion date December 13, 2019
Est. primary completion date December 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Other Postoperative Pain Scores Pain scores range from 0 to 10 with higher score denoting more pain September 2016 to August 2017
Other Postoperative Pain Scores Pain scores range from 0 to 10 with higher score denoting more pain September 2017 to May 2018
Other Postoperative Pain Scores Pain scores range from 0 to 10 with higher score denoting more pain June 2018 to May 2019
Other Time Spent in Post-anesthesia Care Unit (PACU) September 2016 to August 2017
Other Time Spent in Post-anesthesia Care Unit (PACU) September 2017 to May 2018
Other Time Spent in Post-anesthesia Care Unit (PACU) June 2018 to May 2019
Primary Total Fentanyl usage Monthly average amount administered per case per kg September 2016 to August 2017
Primary Total Fentanyl usage Monthly average amount administered per case per kg September 2017 to May 2018
Primary Total Fentanyl usage Monthly average amount administered per case per kg June 2018 to May 2019
Secondary Nonopioid analgesia usage Monthly average amount administered per case per kg September 2016 to August 2017
Secondary Nonopioid analgesia usage Monthly average amount administered per case per kg September 2017 to May 2018
Secondary Nonopioid analgesia usage Monthly average amount administered per case per kg June 2018 to May 2019
Secondary Number of CPR incidents post-operative complication September 2016 to August 2017
Secondary Number of CPR incidents post-operative complication September 2017 to May 2018
Secondary Number of CPR incidents post-operative complication June 2018 to May 2019
Secondary Number of reintubation incidents post-operative complication September 2016 to August 2017
Secondary Number of reintubation incidents post-operative complication September 2017 to May 2018
Secondary Number of reintubation incidents post-operative complication June 2018 to May 2019
Secondary Number of incidents requiring administration of emergency drugs post-operative complication September 2016 to August 2017
Secondary Number of incidents requiring administration of emergency drugs post-operative complication September 2016 to May 2018
Secondary Number of incidents requiring administration of emergency drugs post-operative complication June 2018 to May 2019
Secondary Length of hospital stay September 2016 to August 2017
Secondary Length of hospital stay September 2016 to May 2018
Secondary Length of hospital stay June 2018 to May 2019
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