Trial Outcomes & Findings for IV Acetaminophen for Postoperative Analgesia (NCT NCT01798316)

Results Overview

Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

105 participants

Primary outcome timeframe

4 hours plus/minus 30 minutes

Results posted on

2017-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	IV Acetaminophen IV Acetaminophen administered before PACU admission IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes	Standard of Care Standard of care pain management regimen including opioids Standard of Care: without IV acetaminophen
Overall Study STARTED	52	53
Overall Study COMPLETED	52	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IV Acetaminophen for Postoperative Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Acetaminophen n=52 Participants IV Acetaminophen administered before PACU admission IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes	Standard of Care n=53 Participants Standard of care pain management regimen including opioids Standard of Care: No IV acetaminophen	Total n=105 Participants Total of all reporting groups
Age, Continuous	44.6 years STANDARD_DEVIATION 13.0 • n=99 Participants	44.9 years STANDARD_DEVIATION 12.3 • n=107 Participants	44.7 years STANDARD_DEVIATION 12.6 • n=206 Participants
Sex: Female, Male Female	40 Participants n=99 Participants	40 Participants n=107 Participants	80 Participants n=206 Participants
Sex: Female, Male Male	12 Participants n=99 Participants	13 Participants n=107 Participants	25 Participants n=206 Participants
Region of Enrollment United States	52 participants n=99 Participants	53 participants n=107 Participants	105 participants n=206 Participants

PRIMARY outcome

Timeframe: 4 hours plus/minus 30 minutes

Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=52 Participants IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of Care n=53 Participants Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Number of Participants With Postoperative Nausea and Vomiting (PONV).	15 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to two days following surgery

Population: Post-discharge follow up group. Patients not included in analysis were lost to follow up.

Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge.

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=41 Participants IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of Care n=40 Participants Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Number of Participants With Post Discharge Nausea and Vomiting (PDNV)	4 Participants	10 Participants

SECONDARY outcome

Timeframe: 4 hours plus/minus 30 minutes

Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=52 Participants IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of Care n=53 Participants Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Highest Pain Intensity Score Using Numeric Rating Scale (NRS)	6 Units on a numerical rating scale Interval 5.0 to 8.0	6 Units on a numerical rating scale Interval 4.0 to 8.0

SECONDARY outcome

Timeframe: Up to one week following surgery

Population: Post-discharge follow up group. Patients not included in analysis were lost to follow up.

Number of patients very satisfied or satisfied with pain and PONV management during hospital stay

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=41 Participants IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of Care n=40 Participants Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Patient Satisfaction on a 5 Point Likert Scale	38 Participants	35 Participants

SECONDARY outcome

Timeframe: 1 hour following surgery

Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=52 Participants IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of Care n=53 Participants Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale	3 Units on a numerical rating scale Interval 0.0 to 4.0	3 Units on a numerical rating scale Interval 0.0 to 4.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 hour following surgery

Number of patients requiring rescue analgesia medication during first hour of PACU stay

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=52 Participants IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of Care n=53 Participants Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Number of Patients Requiring Rescue Analgesia for Breakthrough Pain	28 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours plus/minus 30 minutes

Narcotic medication administered during PACU stay in morphine milligram equivalents

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=52 Participants IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of Care n=53 Participants Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Narcotic Use During PACU Stay	13.3 Morphine milligram equivalents Interval 8.5 to 18.0	16.8 Morphine milligram equivalents Interval 10.3 to 23.2

Adverse Events

IV Acetaminophen

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IV Acetaminophen n=52 participants at risk IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of Care n=53 participants at risk Standard of care pain management regimen including opioids administered on admission to PACU No IV acetaminophen
Gastrointestinal disorders Nausea	19.2% 10/52	28.3% 15/53
Nervous system disorders Drowziness	0.00% 0/52	3.8% 2/53
Nervous system disorders Headache	1.9% 1/52	0.00% 0/53
Nervous system disorders Dizziness	1.9% 1/52	1.9% 1/53
Gastrointestinal disorders Vomiting	11.5% 6/52	9.4% 5/53

Additional Information

Director of Clinical Research, Department of Anesthesiology

Northwell

Phone: 718-470-7630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place