Health TrialsbyHealthPanel

Patient Controlled Administration of Liquid Acetaminophen

ConditionsPainPain, Postoperative
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

The nurse who will administer acetaminophen to a study patient.

Disqualifiers

Pregnant patient

Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)

Emergency surgery

Chronic pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetaminophen 650 mg Oral Tablet

    Drug

    650 mg pills

  • Acetaminophen 650mg Liquid

    Drug

    650 mg liquid

  • CADD pump

    Device

    Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Nurse Administered AcetaminophenActive comparator 1 intervention
Group B: CADD pump Administered Acetaminophen (Participant Controlled)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Participant enrollment rate

The percentage of participants that enroll

Time frame
up to 12 months
2

Participant adherence to the study protocol

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
up to 12 months
3

Nurse Questionnaire

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
Study day 0, 1, 2 and 3

Secondary outcomes

1

Mean daily acetaminophen consumption

Mean daily acetaminophen consumption in milligrams collected using the electronic medical record

Time frame
12 months
2

Mean Pain score

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
3

Mean time to medication delivery

Medication delivery: Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Source ClinicalTrials.gov
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