Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924165
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2023-06-20
Brief Title:
Narcotic-Free Percutaneous Nephrolithotomy
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Narcotic-Free Percutaneous Nephrolithotomy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia
Detailed Description:
This is a randomized control trial comparing oral ketorolac 10mg Q6 PRN and oxycodone 5mg Q6 PRN medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy PCNL Primary endpoints are visual analog pain scores VAS for days 1-5 and day 10 post operatively Secondary endpoints are pill counts patient-related outcome survey PROMIS scores emergency room visits and patient telephone calls 90 subjects will be enrolled with 45 in each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None