CompletedNCT03468920Updated May 14, 2019Results posted

Preoperative IV Versus Oral Acetaminophen

A Phase 4 interventional study of IV Acetaminophen and PO Acetaminophen in Pain, Postoperative, sponsored by TriHealth Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-14.

Sponsored by TriHealth Inc. · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 120
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Pain, Postoperative

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Pain, Postoperative 5,640

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 120 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 120 participants (actual)

Study arms

Experimental
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
Drug: IV Acetaminophen · Drug: PO Placebo
Active comparator
Arm 2: PO Acetaminophen group
Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
Drug: PO Acetaminophen · Drug: IV Solution Placebo

Interventions

DrugIV Acetaminophen
IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
Also known as: Tylenol
DrugPO Acetaminophen
Acetaminophen PO 1000mg once pre-operatively
Also known as: Tylenol
DrugPO Placebo
PO placebo capsule compounded to match PO Acetaminophen capsule
DrugIV Solution Placebo
This will serve as the placebo for the IV Acetaminophen intervention
Also known as: IV Normal Saline

What researchers measure

Primary outcomes

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

Secondary outcomes

Number of Participants Who Received Opioid Administration in PACU
Number of Participants who Received Opioid Administration in PACU
Time frame: 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)
Time frame: through study visit, less than 24 hours
Length of Stay
Minutes from entering PACU to end of Phase II
Time frame: 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)
Time frame: up to 2 days after surgery

Results

Posted May 7, 2019

Participant flow

Participant flow — Overall Study
Milestone	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group
Started	60	60
Completed	60	60
Not completed	0	0

Outcome measures

PrimaryPatient Reported Pain

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

Time frame:: through study visit, less than 24 hours
Reported as:: Mean · score on a scale

Patient Reported Pain
score on a scale	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group
Patient Reported Pain	4.12 ± 3.092	4.37 ± 3.226

SecondaryNumber of Participants Who Received Opioid Administration in PACU

Number of Participants who Received Opioid Administration in PACU

Time frame:: through study visit, less than 24 hours
Reported as:: Count of participants · Participants

Number of Participants Who Received Opioid Administration in PACU
Participants	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group
Number of Participants Who Received Opioid Administration in PACU	31	34

SecondaryNumber of Participants Who Experienced Postoperative Nausea and Vomiting

Did patient experience negative effects of pain medication (postoperative nausea and vomiting)

Time frame:: through study visit, less than 24 hours
Reported as:: Count of participants · Participants

Number of Participants Who Experienced Postoperative Nausea and Vomiting
Participants	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group
Number of Participants Who Experienced Postoperative Nausea and Vomiting	8	6

SecondaryLength of Stay

Minutes from entering PACU to end of Phase II

Time frame:: through study visit, less than 24 hours
Reported as:: Mean · minutes

Length of Stay
minutes	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group
Length of Stay	88.25 ± 26.651	92.88 ± 29.911

SecondaryPatient Satisfaction

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
Reported as:: Mean · score on a scale

Patient Satisfaction
score on a scale	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group
Patient Satisfaction	9.45 ± 0.950	9.77 ± 0.528

Adverse events

Collected over 10 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm 1: IV Acetaminophen Group	0/60 (0%)	0/60 (0%)	0/60 (0%)
Arm 2: PO Acetaminophen Group	0/60 (0%)	0/60 (0%)	0/60 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group	Total
Mean	45.37 ± 15.82	46.28 ± 16.84	45.83 ± 16.28

Sex: Female, Male
Sex: Female, Male(Participants)	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group	Total
Female	37	35	72
Male	23	25	48

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Arm 1: IV Acetaminophen Group	Arm 2: PO Acetaminophen Group	Total
United States	60	60	120

Study locations

1 site

TriHealth, Bethesda Butler Hospital
Cincinnati, Ohio 45011, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Mar 1, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Feb 2019, 10 months.

Results were first posted in May 2019, 2 months after primary completion.

Of 531 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's 10 months is below that.

Counting every sponsor, half of 541 studies reached it within 16 months; a quarter within 8 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 1, 2018
First posted: Mar 19, 2018
StartActual: Apr 1, 2018
Primary completionActual: Feb 14, 2019
CompletionActual: Apr 12, 2019
Results first posted: May 7, 2019
Last update: May 14, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03468920
Lead sponsor: TriHealth Inc.
Responsible party: Rachel Baker (Nurse Researcher, TriHealth Inc.) — Principal investigator
First posted: Mar 19, 2018
Start date: Apr 1, 2018
Primary completion: Feb 14, 2019
Completion: Apr 12, 2019
Results posted: May 7, 2019
Last update: May 14, 2019

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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