Opioid Use, Unspecified Clinical Trial
Official title:
The Effects of the Opioid Drug Shortages on Selection of Nonopioid Analgesics During Laparoscopic Cholecystectomy
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 |
Verified date | September 2019 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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.
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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