Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02244619
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2014-09-16
Brief Title:
PO vs IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement
Sponsor:
Kettering Health Network
Organization:
Kettering Health Network
Study Overview
Official Title:
Randomized Double-Blind Study Comparing Oral Acetaminophen Plus Intravenous IV Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement
Status:
COMPLETED
Status Verified Date:
2017-07
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:
KHEA
Brief Summary:
The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen
Detailed Description:
Subjects will be randomized to receive perioperative dosing of either
1 Oral acetaminophen Tylenol 1000mg with IV Placebo 100ml Normal Saline OR
2 IV acetaminophen Ofirmev 1000mg100ml with Oral Placebo oral capsules
Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery
1 Oral acetaminophen Tylenol 1000mg with IV Placebo 100ml Normal Saline OR
2 IV acetaminophen Ofirmev 1000mg100ml with Oral Placebo oral capsules
Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None