Trial Outcomes & Findings for Efficacy of Oral vs. Intravenous Acetaminophen (NCT NCT02643394)

Results Overview

Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

110 participants

Primary outcome timeframe

1-h postoperatively

Results posted on

2020-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Acetaminophen Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen 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 Study STARTED	55	55
Overall Study COMPLETED	51	50
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Acetaminophen Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen 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 Study Protocol Violation	4	5

Baseline Characteristics

Efficacy of Oral vs. Intravenous Acetaminophen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Acetaminophen n=55 Participants Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen n=55 Participants 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 n=110 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=39 Participants	42 Participants n=41 Participants	86 Participants n=35 Participants
Age, Categorical >=65 years	11 Participants n=39 Participants	13 Participants n=41 Participants	24 Participants n=35 Participants
Age, Continuous	51.5 years STANDARD_DEVIATION 16.3 • n=39 Participants	54.0 years STANDARD_DEVIATION 15.7 • n=41 Participants	52.7 years STANDARD_DEVIATION 16.0 • n=35 Participants
Sex: Female, Male Female	21 Participants n=39 Participants	20 Participants n=41 Participants	41 Participants n=35 Participants
Sex: Female, Male Male	34 Participants n=39 Participants	35 Participants n=41 Participants	69 Participants n=35 Participants
Region of Enrollment United States	55 participants n=39 Participants	55 participants n=41 Participants	110 participants n=35 Participants

PRIMARY outcome

Timeframe: 1-h postoperatively

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

Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)

Outcome measures

Outcome measures
Measure	Oral Acetaminophen n=51 Participants Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen n=50 Participants 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.
Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain)	2 units on a scale Interval 0.0 to 3.0	2 units on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: an expected average of 6 hours

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

Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours

Outcome measures

Outcome measures
Measure	Oral Acetaminophen n=51 Participants Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen n=50 Participants 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.
Morphine Equivalents of Postoperative Opioid Usage	5 Morphine equivalent (mg) Interval 0.0 to 10.0	5 Morphine equivalent (mg) Interval 0.0 to 14.8

Adverse Events

Oral Acetaminophen

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Intravenous Acetaminophen

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oral Acetaminophen n=51 participants at risk Oral Acetaminophen 1-hour before surgery Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision	Intravenous Acetaminophen n=50 participants at risk 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.
Gastrointestinal disorders Nausea	5.9% 3/51 • Number of events 3 • Through 24h post-operatively Patient phone call at 24h	12.0% 6/50 • Number of events 6 • Through 24h post-operatively Patient phone call at 24h

Additional Information

David McDonagh, MD

UT Southwestern Medical Center

Phone: 214-648-8083

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place