Self-administered liquid acetaminophen for pain management
Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen Trial
This study is testing whether patients can safely and effectively give themselves liquid acetaminophen for pain relief after shoulder surgery instead of having a nurse do it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06498713 on ClinicalTrials.gov |
What this trial studies
This pilot study explores the feasibility and acceptability of allowing patients to self-administer liquid acetaminophen for pain management after total shoulder surgeries. The study aims to recruit adult patients and assess their willingness to use this method compared to traditional nurse-administered acetaminophen. Key metrics include patient enrollment and adherence rates, as well as the preliminary efficacy of this self-administration approach. Participants will maintain a pain diary and report any issues with medication administration to nursing staff.
Who should consider this trial
Good fit: Ideal candidates are adult patients over 18 years old undergoing total shoulder or reverse total shoulder arthroplasty.
Not a fit: Patients who cannot swallow pills or liquids, have chronic pain, or are on certain pain-modulating medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could empower patients to manage their pain more effectively and improve their overall recovery experience.
How similar studies have performed: While this approach is innovative, similar studies on patient-controlled analgesia have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. 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.
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital at St. Raphael's Campus — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Jinlei Li, MD, PhD — Yale University
- Study coordinator: Jinlei Li, MD, PhD
- Email: jinlei.li@yale.edu
- Phone: 475-434-4038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.