Determine the Clinical Advantage of IV vs PO Acetaminophen

Study Overview
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Brief Summary
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There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.

Detailed Description
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In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.

Official Title
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Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Drug: Acetaminophen IV Soln
* Drug: Oral Acetaminophen
* Drug: Placebo Pills
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA scores I-III Ambulatory surgery patients Ages 18-75 Surgeries requiring general anesthesia for hernia surgery Exclusion Criteria: Patients with contraindications to acetaminophen (history of end organ liver dysfunction) Known allergy to acetaminophen Emergency surgery Patients who were not fasted Patients who cannot tolerate PO Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen Pregnancy Weight less than 50kg Chronic daily narcotic use Patients who's anesthetic plan requires regional anesthesia Patient refusal to participate or do not have capacity to provide consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Acetaminophen<br>Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively. | Drug: Oral Acetaminophen<br>* oral acetaminophen 975mg pills<br>Drug: Saline<br>* Intravenous saline<br>|
| Active Comparator: Acetaminophen IV Soln<br>Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively. | Drug: Acetaminophen IV Soln<br>* 1000mg of IV acetaminophen<br>Drug: Placebo Pills<br>* placebo match to acetaminophen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PACU Visual Analogue Pain Scores | Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain. | baseline, 1 hour, and Day 1 discharge | 
| Total MME Intraoperatively | Total Morphine Milligram Equivalent (MME) use intraoperatively | Day 1 | 
| Total Narcotic Use in PACU. | Total narcotic use in PACU expressed in total morphine milligram equivalents (MME) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PACU Length of Stay | Time in PACU | up to 24 hours after PACU arrival | 
| Patient Reported Total Narcotic Use Post-discharge | home opiod use | average 7 days | 
| Patient Satisfaction. | Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction | 7 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen, Tylenol, Intravenous versus oral