Trial Outcomes & Findings for Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery (NCT NCT01783236)

Results Overview

How much morphine the subject consumes in the first 24 hours after surgery (mg).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

24 hours

Results posted on

2017-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Saline Placebo Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.	IV Acetaminophen Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.
Overall Study STARTED	8	8
Overall Study COMPLETED	6	8
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline Placebo n=8 Participants Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.	IV Acetaminophen n=8 Participants Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.	Total n=16 Participants Total of all reporting groups
Age, Continuous	59.5 years STANDARD_DEVIATION 13.18 • n=5 Participants	64.6 years STANDARD_DEVIATION 8.23 • n=7 Participants	61.8 years STANDARD_DEVIATION 11.28 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

How much morphine the subject consumes in the first 24 hours after surgery (mg).

Outcome measures

Outcome measures
Measure	Saline Placebo n=6 Participants Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.	IV Acetaminophen n=8 Participants Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.
Total Morphine Consumption (mg)	34.5 mg Interval 21.0 to 98.0	44 mg Interval 23.0 to 61.5

SECONDARY outcome

Timeframe: 24 hours post-operation

The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation

Outcome measures

Outcome measures
Measure	Saline Placebo n=6 Participants Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.	IV Acetaminophen n=8 Participants Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.
Total Number of PCA Requests in First 24 Hours Post-Operation	41 PCA requests Interval 17.0 to 144.0	43 PCA requests Interval 25.0 to 85.0

SECONDARY outcome

Timeframe: 2 Hours Post Operation

2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

Outcome measures

Outcome measures
Measure	Saline Placebo n=8 Participants Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.	IV Acetaminophen n=8 Participants Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.
VAS Pain Score 2 Hours Post Operation	75.5 mm Interval 59.0 to 87.5	49 mm Interval 49.0 to 49.0

SECONDARY outcome

Timeframe: 6 Hours Post-Operation

6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

Outcome measures

Outcome measures
Measure	Saline Placebo n=6 Participants Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.	IV Acetaminophen n=8 Participants Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.
VAS Pain Score 6 Hours Post-Operation	68.5 mm Interval 65.0 to 71.0	39 mm Interval 22.5 to 54.5

SECONDARY outcome

Timeframe: 24 hours post-operation

24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).

Outcome measures

Outcome measures
Measure	Saline Placebo n=6 Participants Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.	IV Acetaminophen n=8 Participants Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.
VAS Score 24 Hours Post-Operation	53 mm Interval 29.0 to 67.0	16.5 mm Interval 9.0 to 34.5

Adverse Events

Saline Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

IV Acetaminophen

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Saline Placebo n=8 participants at risk Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.	IV Acetaminophen n=8 participants at risk Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses.
General disorders Inadequate Pain Control	25.0% 2/8 • Number of events 2 • 24 hour study treatment period	0.00% 0/8 • 24 hour study treatment period
General disorders Lethargy	0.00% 0/8 • 24 hour study treatment period	12.5% 1/8 • Number of events 1 • 24 hour study treatment period
General disorders Nausea	12.5% 1/8 • Number of events 1 • 24 hour study treatment period	25.0% 2/8 • Number of events 2 • 24 hour study treatment period
General disorders Headache	12.5% 1/8 • Number of events 1 • 24 hour study treatment period	12.5% 1/8 • Number of events 1 • 24 hour study treatment period

Additional Information

Hugh Hemmings, MD, PhD

Weill Cornell Medicine

Phone: 212-746-2953

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place