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Preoperative IV Versus Oral Acetaminophen

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
PO Acetaminophen
PO Placebo
IV Solution Placebo
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TriHealth, Bethesda Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: IV Acetaminophen group

Arm 2: PO Acetaminophen group

Arm Description

Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively

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

Outcomes

Primary Outcome Measures

Patient Reported Pain
Pain measured from 0 (no pain) to 10 (worst pain)

Secondary Outcome Measures

Number of Participants Who Received Opioid Administration in PACU
Number of Participants who Received Opioid Administration in PACU
Number of Participants Who Experienced Postoperative Nausea and Vomiting
Did patient experience negative effects of pain medication (postoperative nausea and vomiting)
Length of Stay
Minutes from entering PACU to end of Phase II
Patient Satisfaction
Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)

Full Information

First Posted
March 1, 2018
Last Updated
May 6, 2019
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03468920
Brief Title
Preoperative IV Versus Oral Acetaminophen
Official Title
Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
April 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TriHealth Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This study will use a randomized, double-blind, placebo controlled design with two arms.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: IV Acetaminophen group
Arm Type
Experimental
Arm Description
Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
Arm Title
Arm 2: PO Acetaminophen group
Arm Type
Active Comparator
Arm Description
Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
Intervention Type
Drug
Intervention Name(s)
PO Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Acetaminophen PO 1000mg once pre-operatively
Intervention Type
Drug
Intervention Name(s)
PO Placebo
Intervention Description
PO placebo capsule compounded to match PO Acetaminophen capsule
Intervention Type
Drug
Intervention Name(s)
IV Solution Placebo
Other Intervention Name(s)
IV Normal Saline
Intervention Description
This will serve as the placebo for the IV Acetaminophen intervention
Primary Outcome Measure Information:
Title
Patient Reported Pain
Description
Pain measured from 0 (no pain) to 10 (worst pain)
Time Frame
through study visit, less than 24 hours
Secondary Outcome Measure Information:
Title
Number of Participants Who Received Opioid Administration in PACU
Description
Number of Participants who Received Opioid Administration in PACU
Time Frame
through study visit, less than 24 hours
Title
Number of Participants Who Experienced Postoperative Nausea and Vomiting
Description
Did patient experience negative effects of pain medication (postoperative nausea and vomiting)
Time Frame
through study visit, less than 24 hours
Title
Length of Stay
Description
Minutes from entering PACU to end of Phase II
Time Frame
through study visit, less than 24 hours
Title
Patient Satisfaction
Description
Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)
Time Frame
up to 2 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
TriHealth, Bethesda Butler Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Preoperative IV Versus Oral Acetaminophen

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