Preoperative IV Versus Oral Acetaminophen

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-04-12

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.

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will use a randomized, double-blind, placebo controlled design with two arms.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Only pharmacy staff will have randomization scheme and be aware of whether patient received oral Acetaminophen with IV placebo OR if the patient received IV Acetaminophen with oral placebo

Study Groups

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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

Group Type EXPERIMENTAL

IV Acetaminophen

Intervention Type DRUG

IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

PO Placebo

Intervention Type DRUG

PO placebo capsule compounded to match PO Acetaminophen capsule

Arm 2: PO Acetaminophen group

Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively

Group Type ACTIVE_COMPARATOR

PO Acetaminophen

Intervention Type DRUG

Acetaminophen PO 1000mg once pre-operatively

IV Solution Placebo

Intervention Type DRUG

This will serve as the placebo for the IV Acetaminophen intervention

Interventions

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IV Acetaminophen

IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively

Intervention Type DRUG

PO Acetaminophen

Acetaminophen PO 1000mg once pre-operatively

Intervention Type DRUG

PO Placebo

PO placebo capsule compounded to match PO Acetaminophen capsule

Intervention Type DRUG

IV Solution Placebo

This will serve as the placebo for the IV Acetaminophen intervention

Intervention Type DRUG

Other Intervention Names

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Tylenol Tylenol IV Normal Saline

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No