Efficacy of Oral vs. Intravenous Acetaminophen

• ClinicalTrials.gov Identifier: NCT02643394
• Recruitment Status: Completed
• First Posted: December 31, 2015
• Results First Posted: May 7, 2018
• Last Update Posted: July 3, 2018
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): University of Texas Southwestern Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Postoperative Pain
• Interventions: Drug: Oral Acetaminophen; Drug: Intravenous acetaminophen
• Enrollment: 110

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Oral Acetaminophen	Intravenous Acetaminophen
Arm/Group Description	Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen within 1-hour prior to anesthetic emergence Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
Period Title: Overall Study
Started	55	55
Completed	51	50
Not Completed	4	5
Reason Not Completed
Protocol Violation	4	5

Baseline Characteristics

Arm/Group Title		Oral Acetaminophen	Intravenous Acetaminophen	Total
Arm/Group Description		Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen within 1-hour prior to anesthetic emergence Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.	Total of all reporting groups
Overall Number of Baseline Participants		55	55	110
Baseline Analysis Population Description		Adult patients undergoing sinus surgery at a single major academic medical center
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	55 participants	55 participants	110 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	44 80.0%	42 76.4%	86 78.2%
	>=65 years	11 20.0%	13 23.6%	24 21.8%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	55 participants	55 participants	110 participants
		51.5 (16.3)	54.0 (15.7)	52.7 (16.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	55 participants	55 participants	110 participants
	Female	21 38.2%	20 36.4%	41 37.3%
	Male	34 61.8%	35 63.6%	69 62.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	55 participants	55 participants	110 participants
		55	55	110

Outcome Measures

1. Primary Outcome

Title	Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain)
Description	Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)
Time Frame	1-h postoperatively

Outcome Measure Data

Analysis Population Description

Subjects undergoing Functional Endoscopic Sinus Surgery were enrolled to the study.

Arm/Group Title	Oral Acetaminophen	Intravenous Acetaminophen
Arm/Group Description:	Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen within 1-hour prior to anesthetic emergence Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
Overall Number of Participants Analyzed	51	50
Median (Inter-Quartile Range); Unit of Measure: units on a scale
	2; (0 to 3)	2; (0 to 5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oral Acetaminophen, Intravenous Acetaminophen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.252
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

2. Secondary Outcome

Title	Morphine Equivalents of Postoperative Opioid Usage
Description	Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours
Time Frame	an expected average of 6 hours

Outcome Measure Data

Analysis Population Description

Subjects undergoing Functional Endoscopic Sinus Surgery were enrolled to the study.

Arm/Group Title	Oral Acetaminophen	Intravenous Acetaminophen
Arm/Group Description:	Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen within 1-hour prior to anesthetic emergence Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
Overall Number of Participants Analyzed	51	50
Median (Inter-Quartile Range); Unit of Measure: Morphine equivalent (mg)
	5; (0 to 10)	5; (0 to 14.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oral Acetaminophen, Intravenous Acetaminophen
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.402
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Adverse Events

Time Frame	Through 24h post-operatively
Adverse Event Reporting Description	Patient phone call at 24h
Arm/Group Title	Oral Acetaminophen		Intravenous Acetaminophen
Arm/Group Description	Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision		Intravenous Acetaminophen within 1-hour prior to anesthetic emergence Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
All-Cause Mortality
	Oral Acetaminophen		Intravenous Acetaminophen
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/51 (0.00%)		0/50 (0.00%)
Serious Adverse Events
	Oral Acetaminophen		Intravenous Acetaminophen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0.00%)		0/50 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Oral Acetaminophen		Intravenous Acetaminophen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/51 (5.88%)		6/50 (12.00%)
Gastrointestinal disorders
Nausea † [1]	3/51 (5.88%)	3	6/50 (12.00%)	6
† Indicates events were collected by systematic assessment; [1] Nausea following PACU discharge (assessed at 24h post-operatively)

Limitations and Caveats

Single center Sinus surgery population only

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: David McDonagh, MD
• Organization: UT Southwestern Medical Center
• Phone: 214-648-8083
• EMail: david.mcdonagh@utsouthwestern.edu

• Responsible Party: University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02643394 History of Changes
• Other Study ID Numbers: 052015-068
• First Submitted: June 2, 2015
• First Posted: December 31, 2015
• Results First Submitted: November 10, 2017
• Results First Posted: May 7, 2018
• Last Update Posted: July 3, 2018