PainPhase 1NCT06498713
Patient Controlled Administration of Liquid Acetaminophen
A Phase 1 study testing Acetaminophen 650 mg Oral Tablet, Acetaminophen 650mg Liquid and CADD pump in people with Pain and Pain, Postoperative, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pain, Postoperative
- What is being tested?
- Acetaminophen 650 mg Oral Tablet, Acetaminophen 650mg Liquid and CADD pump
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2024to 28 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants
- Adult patients older than 18 years old admitted to SRC for total shoulder and reverse total shoulder arthroplasty
- Nurses
- The nurse who will administer acetaminophen to a study patient.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital at St. Raphael's Campus
New Haven, Connecticut, 06520
About this study
Official title: Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen 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.
Read the 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.
- Conditions
- Pain, Pain, Postoperative
- Being tested
- Acetaminophen 650 mg Oral Tablet, Acetaminophen 650mg Liquid, CADD pump
- Keywords
- Pain Management
- Medical subject headings
- Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen 650 mg Oral TabletDrug
Also called Tylenol
650 mg pills
Acetaminophen 650mg LiquidDrug
Also called Tylenol
650 mg liquid
CADD pumpDevice
Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed.
| Study group | Role | What they receive |
|---|---|---|
| Nurse Administered Acetaminophen | Active comparator | Participants will receive acetaminophen pills 650 mg every 4 hours as needed (PRN) administered by nurse per standard of care Receives: Drug: Acetaminophen 650 mg Oral Tablet |
| CADD pump Administered Acetaminophen (Participant Controlled) | Experimental | 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). Receives: Drug: Acetaminophen 650mg Liquid; Device: CADD pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant enrollment rate
The percentage of participants that enroll
Measured: up to 12 months
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
Measured: up to 12 months
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)
Measured: Study day 0, 1, 2 and 3
Secondary outcomes (3)
Mean daily acetaminophen consumption
Mean daily acetaminophen consumption in milligrams collected using the electronic medical record
Measured: 12 months
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.
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start19 Nov 2024
- Primary completion28 Mar 2026
- Study completion28 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty at Yale New Haven Hospital at St. Raphael's Campus.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale New Haven Hospital
- Responsible party
- Sponsor
- Investigators
- Jinlei Li, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498713
- Sponsor's protocol ID
- 2000037919
- Status last verified
- Aug 2026
- First submitted
- 5 Jul 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen Trial
- ClinicalTrials.gov ID
- NCT06498713
- Acronym / sponsor ID
- 2000037919
- Conditions
- Pain, Pain, Postoperative
- Keywords
- Pain Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Yale New Haven Hospital
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 28 Mar 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty at Yale New Haven Hospital at St. Raphael's Campus.
| Arm | Type | Receives |
|---|---|---|
| Nurse Administered Acetaminophen | Active comparator | Drug: Acetaminophen 650 mg Oral TabletParticipants 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) | Experimental | Drug: Acetaminophen 650mg Liquid, Device: CADD pumpParticipants will receive a CADD pump primed and programmed to deliver 650 mg liquid acetaminophen into a medication cup every 4 hours as needed (PRN). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants
- Adult patients older than 18 years old admitted to SRC for total shoulder and reverse total shoulder arthroplasty
- Nurses
- The nurse who will administer acetaminophen to a study patient.
Key exclusion criteria (15 listed)
- Participants
- Pregnant patient
- Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)
- Emergency surgery
- Chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen 650 mg Oral TabletAlso: Tylenol650 mg pills | Drug | Nurse Administered Acetaminophen |
| Acetaminophen 650mg LiquidAlso: Tylenol650 mg liquid | Drug | CADD pump Administered Acetaminophen (Participant Controlled) |
| CADD pumpPrimed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed. | Device | CADD pump Administered Acetaminophen (Participant Controlled) |
Primary outcome
Participant enrollment rate
Time frame: up to 12 months
The percentage of participants that enroll
Participant adherence to the study protocol
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
Nurse Questionnaire
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)
3 secondary outcomes
Mean daily acetaminophen consumption
Time frame: 12 months
Mean Pain score
Time frame: 12 months
Mean time to medication delivery
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinlei Li, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acetaminophen 650 mg Oral Tablet, Acetaminophen 650mg Liquid and CADD pump in people with Pain and Pain, Postoperative, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant enrollment rate (time frame: up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.