Preoperative IV Versus Oral Acetaminophen

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: IV Acetaminophen
* Drug: PO Acetaminophen
* Drug: PO Placebo
* Drug: IV Solution Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will use a randomized, double-blind, placebo controlled design with two arms.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: IV Acetaminophen group<br>Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively | Drug: IV Acetaminophen<br>* IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively<br>* Other names: Tylenol;Drug: PO Placebo<br>* PO placebo capsule compounded to match PO Acetaminophen capsule<br>|
| Active Comparator: Arm 2: PO Acetaminophen group<br>Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively | Drug: PO Acetaminophen<br>* Acetaminophen PO 1000mg once pre-operatively<br>* Other names: Tylenol;Drug: IV Solution Placebo<br>* This will serve as the placebo for the IV Acetaminophen intervention<br>* Other names: IV Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Pain | Pain measured from 0 (no pain) to 10 (worst pain) | through study visit, less than 24 hours | 

Secondary Outcome Measures

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