[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06498713":3,"trial-entities:NCT06498713":115,"trial-summary:NCT06498713":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":50,"secondary_outcomes":62,"sex":73,"minimum_age":74,"maximum_age":15,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":95,"locations":98,"central_contacts":108,"overall_officials":109,"references":113,"see_also_links":114},"NCT06498713","2000037919","Patient Controlled Administration of Liquid Acetaminophen","Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen Trial","COMPLETED","2026-03-28","2026-08","2026-08-06","2024-11-19","Yale University","OTHER",null,"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.","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.\n\nThe secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration.\n\nIf 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.\n\nAll 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.\n\nAll other medications, such as NSAIDs or oral opioids, will be administered as prescribed.\n\nParticipants will have to fill out a paper questionnaire and keep a pain diary, and nurses will have to fill out a questionnaire.",[19,20],"Pain","Pain, Postoperative",[22],"Pain Management","INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},24,"ACTUAL",[31,39,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"DRUG","Acetaminophen 650 mg Oral Tablet","650 mg pills",[36],"Nurse Administered Acetaminophen",[38],"Tylenol",{"type":32,"name":40,"description":41,"armGroupLabels":42,"otherNames":44},"Acetaminophen 650mg Liquid","650 mg liquid",[43],"CADD pump Administered Acetaminophen (Participant Controlled)",[38],{"type":46,"name":47,"description":48,"armGroupLabels":49},"DEVICE","CADD pump","Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed.",[43],[51,55,58],{"measure":52,"description":53,"timeFrame":54},"Participant enrollment rate","The percentage of participants that enroll","up to 12 months",{"measure":56,"description":57,"timeFrame":54},"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",{"measure":59,"description":60,"timeFrame":61},"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)","Study day 0, 1, 2 and 3",[63,67,70],{"measure":64,"description":65,"timeFrame":66},"Mean daily acetaminophen consumption","Mean daily acetaminophen consumption in milligrams collected using the electronic medical record","12 months",{"measure":68,"description":69,"timeFrame":66},"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.",{"measure":71,"description":72,"timeFrame":66},"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","ALL","18 Years",false,{"inclusion":77,"exclusion":80,"raw_text":94},[78,79],"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.",[81,82,83,84,85,86,87,88,89,90,91,92,93],"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.","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.","Inclusion Criteria:\n\nParticipants\n\n* Adult patients older than 18 years old admitted to SRC for total shoulder and reverse total shoulder arthroplasty\n\nNurses\n\n* The nurse who will administer acetaminophen to a study patient.\n\nExclusion Criteria:\n\nParticipants\n\n* Pregnant patient\n* Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)\n* Emergency surgery\n* Chronic pain\n* On home opioids, any other pain modulating medications including benzodiazepine, Neurontin, ketamine.\n* Past medical or social history of substance abuse disorder, including ethanol misuse disorder, marijuana misuse disorder\n* History of any psychiatric disorders including anxiety, depression, any cognitive dysfunction\n* Any patients who cannot provide informed consents on their own (those who would need Legally Authorized Representatives (LARs) or surrogates)\n* Liver dysfunction limiting amount of safe oral acetaminophen\n* baseline hyperbilirubinemia (ex: chronic liver disease, Gilbert's)\n* patients unable to take PO\n* Patients with neurologic, neuromuscular, or movement disorders unable to drink from a cup.\n\nNurses\n\n* 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.",[96,97],"ADULT","OLDER_ADULT",[99],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"Yale New Haven Hospital at St. Raphael's Campus","New Haven","Connecticut","06520","United States",{"lat":106,"lon":107},41.30815,-72.92816,[],[110],{"name":111,"affiliation":13,"role":112},"Jinlei Li, MD, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":117},[19],[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional pilot study with a planned enrollment of 24 adult participants. It compares patient-controlled liquid acetaminophen to nurse-administered acetaminophen pills.","completed","Patient-Controlled Liquid Acetaminophen for Postoperative Pain","This study is testing a new way to give pain medication after shoulder surgery. It's looking at whether patients can safely and effectively control their own doses of liquid acetaminophen (Tylenol) using a special pump, compared to getting acetaminophen pills from a nurse. We want to see if patients like this method and if it's practical for hospitals. You might be able to join if you are an adult having total shoulder or reverse total shoulder arthroplasty (shoulder replacement surgery). The study aims to enroll 24 participants and is currently unclear on its recruitment status. Success for this study means many patients choose to participate and stick with the new method.","Participant adherence to the study protocol and nurse questionnaires are measured for up to 12 months, and on study days 0, 1, 2, and 3.",111,"You would fill out a paper questionnaire and keep a pain diary. Nurses involved would also fill out a questionnaire.","Not stated in the trial record.",[],"v2"]