Yale New Haven Hospital at St. Raphael's Campus
New Haven, Connecticut, 06520, United States
Location status: Recruiting
NCT Number: NCT06498713
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06520, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants
Nurses
Exclusion criteria
Participants
Nurses
650 mg pills
Other names: Tylenol
650 mg liquid
Other names: Tylenol
Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed.
Time frame: up to 12 months
The percentage of participants that enroll
Time frame: up to 12 months
Percentage of participants that withdraw from treatment group, i.e. switch from patient controlled liquid group to the nurse-administered pill control group
Time frame: Study day 0, 1, 2 and 3
Nurse ranking of patient controlled liquid oral acetaminophen vs. nurse-administered pill acetaminophen. (Mean score, Total Scale of 0-10: 0: much worse; 5:same; 10: much better)
Time frame: 12 months
Mean daily acetaminophen consumption in milligrams collected using the electronic medical record
Time frame: 12 months
Participants will be asked via Pain Diary to rate their pain using numeric pain scores from 0 to 10, 0 as no pain, 10 is the worst possible.
Time frame: 12 months
Medication delivery: Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered
Contact information is provided by the study sponsor or research team.
Yale University
Other
Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04659317
Agnosia, Nervous System Diseases
Atlanta, Georgia, United States
View Trial DetailsNCT06713044
Agnosia, Inflammation
Purwokerto, Central Java, Indonesia
View Trial DetailsNCT04343807
Agnosia, Anaesthesia
Karachi, Sindh, Pakistan
View Trial DetailsNCT03380949
Agnosia, Analgesia
Hamburg, Germany
View Trial Details