Trial Outcomes & Findings for Intravenous Acetaminophen in Craniotomy (NCT NCT01598701)

Results Overview

Opioid Consumption will be monitored in the first 24 post-operative hours. All non-opioid analgesics are disallowed. Total opioid consumption was calculated based on morphine equivalents (MEs), where 1 mg of IV morphine was equivalent to 1 ME, and 1 mg IV hydromorphone was calculated as 7 MEs.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

24 hours post-operatively

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Acetaminophen Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes. Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.	Placebo Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen. Placebo: 100 mL 0.9% Sodium Chloride
Overall Study STARTED	50	50
Overall Study COMPLETED	45	41
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravenous Acetaminophen in Craniotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Acetaminophen n=50 Participants Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes. Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.	Placebo n=50 Participants Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen. Placebo: 100 mL 0.9% Sodium Chloride	Total n=100 Participants Total of all reporting groups
Age, Continuous	50.0 years STANDARD_DEVIATION 16.3 • n=5 Participants	51.5 years STANDARD_DEVIATION 14.4 • n=7 Participants	50.75 years STANDARD_DEVIATION 15.35 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	31 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	19 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post-operatively

Opioid Consumption will be monitored in the first 24 post-operative hours. All non-opioid analgesics are disallowed. Total opioid consumption was calculated based on morphine equivalents (MEs), where 1 mg of IV morphine was equivalent to 1 ME, and 1 mg IV hydromorphone was calculated as 7 MEs.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=45 Participants Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes. Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.	Placebo n=41 Participants Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen. Placebo: 100 mL 0.9% Sodium Chloride
Post-Operative Opioid Requirement	11.0 Morphine Equivalents Interval 2.0 to 21.0	10.1 Morphine Equivalents Interval 1.0 to 16.7

SECONDARY outcome

Timeframe: 24 Hours Post-Operatively

Patients will be assessed for pain using a Visual Analogue Scale (VAS) Scale at set time points after surgery (0,1,2,4,8,12,16,20,24 hours post-operatively). The Visual Analogue Scale (VAS) scale was measured on a scale of 0 - 10 (0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Higher values on the VAS represent a worse outcome. The two rows below report: 1. the average VAS score for the least amount of pain reported per group and 2. the average VAS score of the worst amount of pain reported per group.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=45 Participants Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes. Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.	Placebo n=41 Participants Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen. Placebo: 100 mL 0.9% Sodium Chloride
Post-Operative Pain Least amount of pain reported	1.4 units on a scale Standard Deviation 1.8	2.6 units on a scale Standard Deviation 2.7
Post-Operative Pain Worst amount of pain reported	6.3 units on a scale Standard Deviation 2.5	6.4 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 24 Hours Post-Operatively

Population: The # analyzed does not match the # who completed or the overall # analyzed because data on all side effects was not collected for all participants who completed, either due to lack of collection of data by research/nursing staff (for emesis) or due to lack of reporting by participants on a questionnaire(for itching, dizziness, and drowsiness).

Patients will be monitored for 24 hours post-operatively to detect the incidence of any drug or opioid-related side effects. These side effects were not considered to be adverse events.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=45 Participants Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes. Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.	Placebo n=40 Participants Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen. Placebo: 100 mL 0.9% Sodium Chloride
Post-Operative Side Effects Dizziness	14 Participants	14 Participants
Post-Operative Side Effects Drowsiness	24 Participants	19 Participants
Post-Operative Side Effects Emesis	23 Participants	20 Participants
Post-Operative Side Effects Itching	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Time from of discontinuation of anesthetic to time of extubation, an average of 7 minutes

Population: The number analyzed is greater than the number completed because this data was collected for more patients than completed the study, and all data that was collected is reported here.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=48 Participants Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes. Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.	Placebo n=45 Participants Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen. Placebo: 100 mL 0.9% Sodium Chloride
Time to Extubation at Emergence From Anesthesia	6 minutes Interval 3.0 to 13.0	8 minutes Interval 5.0 to 12.0

SECONDARY outcome

Timeframe: From time of entry to PACU to time to meet PACU discharge criteria, an average of 12 minutes

Population: The number analyzed is greater than the number completed because this data was collected for more patients than completed the study, and all data that was collected is reported here.

Outcome measures

Outcome measures
Measure	Intravenous Acetaminophen n=46 Participants Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes. Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.	Placebo n=43 Participants Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen. Placebo: 100 mL 0.9% Sodium Chloride
Time for Patient to Meet Post-anesthesia Care Unit (PACU) Discharge Criteria	11.4 minutes Standard Deviation 7.2	13.5 minutes Standard Deviation 8.4

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: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intravenous Acetaminophen n=50 participants at risk Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes. Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.	Placebo n=50 participants at risk Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen. Placebo: 100 mL 0.9% Sodium Chloride
Cardiac disorders Bradycardia	0.00% 0/50	2.0% 1/50 • Number of events 1

Additional Information

Carlos Artime, MD

University of Texas Health Science Center at Houston

Phone: 713-500-6200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place