Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498713
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Patient Controlled Administration of Liquid Acetaminophen
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Patient Controlled Self-Administration of Oral Liquid Medication Acetaminophen Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration using the commonly used and low risk medication in the hospital oral acetaminophen
Detailed Description:
The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using recruitment rate and adherence to the study protocol rate as surrogate markers Investigators hypothesize that patients will accept the new concept of self-controlled oral administration of liquid acetaminophen with more than 50 patient enrollment rate and less than 20 withdrawal rate from the study group to the traditional nurse-administered acetaminophen pills
The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration
If the medication is spilled or otherwise not dispensed correctly the patients will be instructed to report this instantly to the nurse The nurse will document and provide a replacement
All study participants have the option to call the nurse for assistance with break through pain In addition there is a call button to call for help with any other needs or discomfort
All other medications such as NSAIDs or oral opioids will be administered as prescribed
Participants will have to fill out a paper questionnaire and keep a pain diary and nurses will have to fill out a questionnaire
The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration
If the medication is spilled or otherwise not dispensed correctly the patients will be instructed to report this instantly to the nurse The nurse will document and provide a replacement
All study participants have the option to call the nurse for assistance with break through pain In addition there is a call button to call for help with any other needs or discomfort
All other medications such as NSAIDs or oral opioids will be administered as prescribed
Participants will have to fill out a paper questionnaire and keep a pain diary and nurses will have to fill out a questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None