Trial Outcomes & Findings for Preoperative IV Versus Oral Acetaminophen (NCT NCT03468920)

NCT ID: NCT03468920

Last Updated: 2019-05-14

Results Overview

Pain measured from 0 (no pain) to 10 (worst pain)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 120 participants
• Primary outcome timeframe: through study visit, less than 24 hours
• Results posted on: 2019-05-14

Participant Flow

Participant milestones

Measure	Arm 1: IV Acetaminophen Group Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule	Arm 2: PO Acetaminophen Group Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Arm 1: IV Acetaminophen Group n=60 Participants Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule	Arm 2: PO Acetaminophen Group n=60 Participants Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention	Total n=120 Participants Total of all reporting groups
Age, Continuous	45.37 years STANDARD_DEVIATION 15.82 • n=60 Participants	46.28 years STANDARD_DEVIATION 16.84 • n=60 Participants	45.83 years STANDARD_DEVIATION 16.28 • n=120 Participants
Sex: Female, Male Female	37 Participants n=60 Participants	35 Participants n=60 Participants	72 Participants n=120 Participants
Sex: Female, Male Male	23 Participants n=60 Participants	25 Participants n=60 Participants	48 Participants n=120 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	60 participants n=60 Participants	60 participants n=60 Participants	120 participants n=120 Participants

PRIMARY outcome

Timeframe: through study visit, less than 24 hours

Pain measured from 0 (no pain) to 10 (worst pain)

Outcome measures

Measure	Arm 1: IV Acetaminophen Group n=60 Participants Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule	Arm 2: PO Acetaminophen Group n=60 Participants Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention
Patient Reported Pain	4.12 score on a scale Standard Deviation 3.092	4.37 score on a scale Standard Deviation 3.226

SECONDARY outcome

Timeframe: through study visit, less than 24 hours

Number of Participants who Received Opioid Administration in PACU

Outcome measures

Measure	Arm 1: IV Acetaminophen Group n=60 Participants Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule	Arm 2: PO Acetaminophen Group n=60 Participants Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention
Number of Participants Who Received Opioid Administration in PACU	31 Participants	34 Participants

SECONDARY outcome

Timeframe: through study visit, less than 24 hours

Did patient experience negative effects of pain medication (postoperative nausea and vomiting)

Outcome measures

Measure	Arm 1: IV Acetaminophen Group n=60 Participants Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule	Arm 2: PO Acetaminophen Group n=60 Participants Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention
Number of Participants Who Experienced Postoperative Nausea and Vomiting	8 Participants	6 Participants

SECONDARY outcome

Timeframe: through study visit, less than 24 hours

Minutes from entering PACU to end of Phase II

Outcome measures

Measure	Arm 1: IV Acetaminophen Group n=60 Participants Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule	Arm 2: PO Acetaminophen Group n=60 Participants Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention
Length of Stay	88.25 minutes Standard Deviation 26.651	92.88 minutes Standard Deviation 29.911

SECONDARY outcome

Timeframe: up to 2 days after surgery

Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)

Outcome measures

Measure	Arm 1: IV Acetaminophen Group n=60 Participants Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule	Arm 2: PO Acetaminophen Group n=60 Participants Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention
Patient Satisfaction	9.45 score on a scale Standard Deviation 0.950	9.77 score on a scale Standard Deviation 0.528

Adverse Events

Arm 1: IV Acetaminophen Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: PO Acetaminophen Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nurse Researcher

TriHealth

Phone: 513-569-6191

Email: Rachel_Baker2@trihealth.com

Results disclosure agreements

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