Trial Outcomes & Findings for Time of Intravenous Acetaminophen Administration (NCT NCT01699815)

NCT ID: NCT01699815

Last Updated: 2014-09-05

Results Overview

To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 126 participants
• Primary outcome timeframe: preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug
• Results posted on: 2014-09-05

Participant Flow

Participant milestones

Measure	Preemptive Group The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert. Acetaminophen	Closure Group The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure. Acetaminophen
Overall Study STARTED	62	64
Overall Study COMPLETED	57	56
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Measure	Preemptive Group The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert. Acetaminophen	Closure Group The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure. Acetaminophen
Overall Study Protocol Violation	4	7
Overall Study record could not be located	1	0
Overall Study Adverse Event	0	1

Baseline Characteristics

Time of Intravenous Acetaminophen Administration

Baseline characteristics by cohort

Measure	Preemptive Group n=57 Participants The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert. Acetaminophen	Closure Group n=56 Participants The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure. Acetaminophen	Total n=113 Participants Total of all reporting groups
Age, Continuous	60.5 years n=5 Participants	61.7 years n=7 Participants	61.1 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants	56 Participants n=7 Participants	113 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	18 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	38 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	56 participants n=7 Participants	113 participants n=5 Participants

PRIMARY outcome

Timeframe: preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug

To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain

Outcome measures

Measure	Preemptive Group n=57 Participants The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert. Acetaminophen	Closure Group n=56 Participants The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure. Acetaminophen
Changes in Postoperative Pain Scores PACU arrival (2-3 hour)	0.9 units on a scale Standard Deviation 2.3	1.5 units on a scale Standard Deviation 3.1
Changes in Postoperative Pain Scores preoperatively (baseline)	2.7 units on a scale Standard Deviation 1.41	2.5 units on a scale Standard Deviation 2.69
Changes in Postoperative Pain Scores 6 hrs post study drug	2.6 units on a scale Standard Deviation 2.75	2.6 units on a scale Standard Deviation 2.21
Changes in Postoperative Pain Scores 12 hrs post study drug	2.5 units on a scale Standard Deviation 2.69	2.3 units on a scale Standard Deviation 2.05
Changes in Postoperative Pain Scores 18 hrs post study drug	2.7 units on a scale Standard Deviation 2.45	2.6 units on a scale Standard Deviation 2.28
Changes in Postoperative Pain Scores 24 hrs post study drug	3.0 units on a scale Standard Deviation 2.53	2.9 units on a scale Standard Deviation 2.44

SECONDARY outcome

Timeframe: Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug

Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.

Outcome measures

Measure	Preemptive Group n=57 Participants The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert. Acetaminophen	Closure Group n=56 Participants The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure. Acetaminophen
Pain Medication Consumption Rates	50 participants	42 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to discharge (1-4 days)

To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.

Outcome measures

Measure	Preemptive Group n=57 Participants The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert. Acetaminophen	Closure Group n=56 Participants The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure. Acetaminophen
Average Length of Stay (LOS)	2.5 days Standard Deviation 0.5	2.0 days Standard Deviation 0

Adverse Events

Preemptive Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Closure Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Preemptive Group n=57 participants at risk The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended for OfirmevTM administration. Acetaminophen	Closure Group n=56 participants at risk The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure. Acetaminophen
Nervous system disorders Seizure	0.00% 0/57	1.8% 1/56

Additional Information

Virginia C. Muckler

Duke University School of Nursing

Phone: 919-684-9307

Email: chris.muckler@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place