Trial Outcomes & Findings for Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients (NCT NCT01527942)

Results Overview

The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

baseline and 24 hours

Results posted on

2015-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 - Active Drug Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Acetaminophen: Intravenous Acetaminophen 1,000 mg IV	Arm 2 - Placebo Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Placebo: Placebo - IV administration 0.9% 100 ml NaCl
Overall Study STARTED	16	18
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 - Active Drug n=16 Participants Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Acetaminophen: Intravenous Acetaminophen 1,000 mg IV	Arm 2 - Placebo n=18 Participants Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Placebo: Placebo - IV administration 0.9% 100 ml NaCl	Total n=34 Participants Total of all reporting groups
Age, Customized 20 to 70 Years	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 24 hours

Population: Study was terminated - data were determined to be unusable by IRB due to consent issues.

The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 24 hours

Population: Study was terminated - data were determined to be unusable by IRB due to consent issues.

The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours after baseline

Population: Study was terminated - data were determined to be unusable by IRB due to consent issues.

The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.

Outcome measures

Outcome data not reported

Adverse Events

Arm 1 - Active Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2 - Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 - Active Drug n=16 participants at risk Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Acetaminophen: Intravenous Acetaminophen 1,000 mg IV	Arm 2 - Placebo n=18 participants at risk Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Placebo: Placebo - IV administration 0.9% 100 ml NaCl
Cardiac disorders Death	0.00% 0/16 • Adverse event data was collected for 24 hours after patients received either active drug or placebo	5.6% 1/18 • Number of events 1 • Adverse event data was collected for 24 hours after patients received either active drug or placebo

Other adverse events

Adverse event data not reported

Additional Information

Ioannis Raftopoulos, MD

ST. FRANCIS HOSPITAL AND MEDICAL CENTER

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place