Preoperative IV Versus Oral Acetaminophen

Phase 4

Completed

Interventions: Drug: PO Acetaminophen
Drug: IV Acetaminophen
Drug: PO Placebo
Drug: IV Solution Placebo

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.

Recruitment & Eligibility

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
Pregnant
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

Arm && Interventions

Group	Intervention	Description
Arm 2: PO Acetaminophen group	PO Acetaminophen	Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
Arm 1: IV Acetaminophen group	PO Placebo	Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
Arm 1: IV Acetaminophen group	IV Acetaminophen	Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
Arm 2: PO Acetaminophen group	IV Solution Placebo	Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

Primary Outcome Measures

Name	Time	Method
Patient Reported Pain	through study visit, less than 24 hours	Pain measured from 0 (no pain) to 10 (worst pain)

Secondary Outcome Measures

Name	Time	Method
Length of Stay	through study visit, less than 24 hours	Minutes from entering PACU to end of Phase II
Number of Participants Who Experienced Postoperative Nausea and Vomiting	through study visit, less than 24 hours	Did patient experience negative effects of pain medication (postoperative nausea and vomiting)
Patient Satisfaction	up to 2 days after surgery	Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)
Number of Participants Who Received Opioid Administration in PACU	through study visit, less than 24 hours	Number of Participants who Received Opioid Administration in PACU