Patient Controlled Administration of Liquid Acetaminophen

Phase 1

Recruiting

Interventions: Drug: Acetaminophen 650 mg Oral Tablet
Drug: Acetaminophen 650mg Liquid
Device: CADD pump

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.

Recruitment & Eligibility

Inclusion Criteria

Participants

Adult patients older than 18 years old admitted to SRC for total shoulder and reverse total shoulder arthroplasty

Nurses

Exclusion Criteria

Participants

Pregnant patient
Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)
Emergency surgery
Chronic pain
On home opioids, any other pain modulating medications including benzodiazepine, Neurontin, ketamine.
Past medical or social history of substance abuse disorder, including ethanol misuse disorder, marijuana misuse disorder
History of any psychiatric disorders including anxiety, depression, any cognitive dysfunction
Any patients who cannot provide informed consents on their own (those who would need Legally Authorized Representatives (LARs) or surrogates)
Liver dysfunction limiting amount of safe oral acetaminophen
baseline hyperbilirubinemia (ex: chronic liver disease, Gilbert's)
patients unable to take PO
Patients with neurologic, neuromuscular, or movement disorders unable to drink from a cup.

Nurses

any nurse who is not involved in the direct care of a study patient, or who is not comfortable with setting up the PCA pump.

Arm && Interventions

Group	Intervention	Description
Nurse Administered Acetaminophen	Acetaminophen 650 mg Oral Tablet	Participants will receive acetaminophen pills 650 mg every 4 hours as needed (PRN) administered by nurse per standard of care
CADD pump Administered Acetaminophen (Participant Controlled)	Acetaminophen 650mg Liquid	Participants will receive a CADD pump primed and programmed to deliver 650 mg liquid acetaminophen into a medication cup every 4 hours as needed (PRN).
CADD pump Administered Acetaminophen (Participant Controlled)	CADD pump	Participants will receive a CADD pump primed and programmed to deliver 650 mg liquid acetaminophen into a medication cup every 4 hours as needed (PRN).

Primary Outcome Measures

Name	Time	Method
Participant enrollment rate	up to 12 months	The percentage of participants that enroll
Participant adherence to the study protocol	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
Nurse Questionnaire	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)

Secondary Outcome Measures

Name	Time	Method
Mean daily acetaminophen consumption	12 months	Mean daily acetaminophen consumption in milligrams collected using the electronic medical record
Mean Pain score	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.
Mean time to medication delivery	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

Locations (1): Yale New Haven Hospital at St. Raphael's Campus
🇺🇸
New Haven, Connecticut, United States