Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen
Overview
- Phase
- Phase 4
- Intervention
- IV Acetaminophen
- Conditions
- Pain, Postoperative
- Sponsor
- TriHealth Inc.
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Patient Reported Pain
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.
Detailed Description
This study will use a randomized, double-blind, controlled design with two arms: Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively 120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.
Investigators
Rachel Baker
Nurse Researcher
TriHealth Inc.
Eligibility Criteria
Inclusion Criteria
- •18 years old or older
- •Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia
Exclusion Criteria
- •Allergy to Acetaminophen
- •Lactose intolerance or lactose allergy (placebo capsules contain lactose)
- •Hepatic disease
- •Having taken a product containing acetaminophen within 6 hours of scheduled surgery time
- •Weight less than 50kg
- •Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse
- •Emergent or on-call procedures
- •Inpatient surgery
Arms & Interventions
Arm 1: IV Acetaminophen group
Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
Intervention: IV Acetaminophen
Arm 1: IV Acetaminophen group
Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
Intervention: PO Placebo
Arm 2: PO Acetaminophen group
Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
Intervention: PO Acetaminophen
Arm 2: PO Acetaminophen group
Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
Intervention: IV Solution Placebo
Outcomes
Primary Outcomes
Patient Reported Pain
Time Frame: through study visit, less than 24 hours
Pain measured from 0 (no pain) to 10 (worst pain)
Secondary Outcomes
- Length of Stay(through study visit, less than 24 hours)
- Number of Participants Who Experienced Postoperative Nausea and Vomiting(through study visit, less than 24 hours)
- Patient Satisfaction(up to 2 days after surgery)
- Number of Participants Who Received Opioid Administration in PACU(through study visit, less than 24 hours)