Trial Outcomes & Findings for Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) (NCT NCT02369211)

Results Overview

The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

86 participants

Primary outcome timeframe

approximately 30-240 min

Results posted on

2019-09-11

Participant Flow

Patients were recruited in the preoperative assessment clinic prior to undergoing surgery

Participant milestones

Participant milestones
Measure	Intravenous Acetaminophen Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Placebo Patient receives saline injection instead of the study drug Placebo
Overall Study STARTED	43	43
Overall Study COMPLETED	43	41
Overall Study NOT COMPLETED	0	2

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=43 Participants Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Placebo n=41 Participants Patient receives saline injection instead of the study drug Placebo	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=43 Participants	0 Participants n=41 Participants	0 Participants n=84 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=43 Participants	16 Participants n=41 Participants	30 Participants n=84 Participants
Age, Categorical >=65 years	29 Participants n=43 Participants	25 Participants n=41 Participants	54 Participants n=84 Participants
Age, Continuous	63.6 years STANDARD_DEVIATION 6.1 • n=43 Participants	60.2 years STANDARD_DEVIATION 6.3 • n=41 Participants	61.7 years STANDARD_DEVIATION 6.0 • n=84 Participants
Sex: Female, Male Female	0 Participants n=43 Participants	0 Participants n=41 Participants	0 Participants n=84 Participants
Sex: Female, Male Male	43 Participants n=43 Participants	41 Participants n=41 Participants	84 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	43 participants n=43 Participants	41 participants n=41 Participants	84 participants n=84 Participants

PRIMARY outcome

Timeframe: approximately 30-240 min

Population: Patients who had surgery and were then transferred to the post-anesthesia care unit for recovery.

The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=34 Participants Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Placebo n=41 Participants Patient receives saline injection instead of the study drug Placebo
Post Anesthesia Care Unit Length of Stay	124 minutes Standard Deviation 58.26	132 minutes Standard Deviation 62.58

PRIMARY outcome

Timeframe: 1-3 days

Population: Patients who were admitted to the hospital (as inpatients) following surgery and post-anesthesia care unit stay.

This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=34 Participants Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Placebo n=41 Participants Patient receives saline injection instead of the study drug Placebo
Hospital Length of Stay	0.81 Days Interval 0.71 to 0.9	0.82 Days Interval 0.66 to 0.95

SECONDARY outcome

Timeframe: 0-24 hours after surgery

Population: Patients who were assessed for levels of pain following surgery, including both treatment and placebo arms.

Pain scores were collected using the Visual Analog Scale. The scale range is 0 (no pain) to 10 (most pain). Mean pain score over first 24 hours postoperatively was collected.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=41 Participants Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Placebo n=43 Participants Patient receives saline injection instead of the study drug Placebo
Pain Score	0.62 score on a scale Interval 0.13 to 1.0	0.88 score on a scale Interval 0.38 to 2.0

SECONDARY outcome

Timeframe: 0-24 hours

Population: Patients who underwent surgery and stayed in the hospital as inpatients and received pain management.

A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=43 Participants Patient receives 1g intravenous acetaminophen after the incision Acetaminophen (Ofirmev)	Placebo n=41 Participants Patient receives saline injection instead of the study drug Placebo
Opioid Use	42 morphine milligram equivalents Interval 36.4 to 50.0	50 morphine milligram equivalents Interval 35.6 to 72.0

Adverse Events

Intravenous Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

James Webber

Brigham and Women's Hospital

Phone: (617) 732-6877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place