Trial Outcomes & Findings for Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy (NCT NCT02025634)

Results Overview

To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

119 participants

Primary outcome timeframe

up to 8 hours

Results posted on

2020-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Acetaminophen Infusion of Intravenous acetaminophen (Ofirmev) Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.	Placebo (0.9% Normal Saline Infusion) Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS
Overall Study STARTED	65	54
Overall Study COMPLETED	65	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Acetaminophen n=65 Participants Infusion of Intravenous acetaminophen (Ofirmev) Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.	Placebo (0.9% Normal Saline Infusion) n=54 Participants Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS	Total n=119 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=65 Participants	0 Participants n=54 Participants	0 Participants n=119 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=65 Participants	34 Participants n=54 Participants	74 Participants n=119 Participants
Age, Categorical >=65 years	25 Participants n=65 Participants	20 Participants n=54 Participants	45 Participants n=119 Participants
Sex: Female, Male Female	34 Participants n=65 Participants	32 Participants n=54 Participants	66 Participants n=119 Participants
Sex: Female, Male Male	31 Participants n=65 Participants	22 Participants n=54 Participants	53 Participants n=119 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: up to 8 hours

To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=65 Participants Infusion of Intravenous acetaminophen (Ofirmev) Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.	Placebo (0.9% Normal Saline Infusion) n=54 Participants Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS
Postoperative Pain Levels	1.3160 score on a scale Standard Deviation 1.33510	2.1362 score on a scale Standard Deviation 1.59323

SECONDARY outcome

Timeframe: up to 8 hours

To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=65 Participants Infusion of Intravenous acetaminophen (Ofirmev) Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.	Placebo (0.9% Normal Saline Infusion) n=54 Participants Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS
Postoperative Opioid Consumption	3 mg Interval 0.0 to 50.0	2 mg Interval 0.0 to 28.1

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 8.6 hours

To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=65 Participants Infusion of Intravenous acetaminophen (Ofirmev) Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.	Placebo (0.9% Normal Saline Infusion) n=54 Participants Infusion of 100 ml of 0.9 NS Normal Saline Placebo (0.9% Normal Saline infusion): Infusion of 100 ml of 0.9% NS
Total Time in Post Anesthesia Care Unit (PACU) (or "Recovery Room")	3.30 hours Interval 1.08 to 5.22	3.40 hours Interval 1.23 to 8.6

Adverse Events

Intravenous Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (0.9% Normal Saline Infusion)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brad Homan

AdventHealth

Phone: 407-303-4270

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place