NCT06498713

Patient Controlled Administration of Liquid Acetaminophen

Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen Trial

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Acetaminophen 650 mg Oral Tablet	650 mg pills
DRUG	Acetaminophen 650mg Liquid	650 mg liquid
DEVICE	CADD pump	Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed.

Timeline

• Start date: 2024-11-19
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-07-12
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study