Trial Outcomes & Findings for Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen (NCT NCT02994940)

NCT ID: NCT02994940

Last Updated: 2021-02-18

Results Overview

Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 74 participants
• Primary outcome timeframe: Within 24hrs
• Results posted on: 2021-02-18

Participant Flow

Participant milestones

Measure	Oral Acetaminophen Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen	Intravenous Acetaminophen Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen
Overall Study STARTED	37	37
Overall Study COMPLETED	30	36
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Measure	Oral Acetaminophen Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen	Intravenous Acetaminophen Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen
Overall Study Did not receive study medications: Study drug not available prior to anesthesia induction	6	0
Overall Study Did not receive study medications: vomited after ingestion	1	0
Overall Study Did not receive study medications: red dye allergy	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Oral Acetaminophen n=30 Participants Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen	Intravenous Acetaminophen n=36 Participants Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen	Total n=66 Participants Total of all reporting groups
Age, Continuous	4 years n=30 Participants	6 years n=36 Participants	5 years n=66 Participants
Sex: Female, Male Female	15 Participants n=30 Participants	14 Participants n=36 Participants	29 Participants n=66 Participants
Sex: Female, Male Male	15 Participants n=30 Participants	22 Participants n=36 Participants	37 Participants n=66 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Weight (kg)	19.3 kg n=30 Participants	20.6 kg n=36 Participants	20.2 kg n=66 Participants
Percentile weight for age	55.0 percentile n=30 Participants	45.0 percentile n=36 Participants	49.5 percentile n=66 Participants

PRIMARY outcome

Timeframe: Within 24hrs

Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery.

Outcome measures

Measure	Oral Acetaminophen n=30 Participants Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen	Intravenous Acetaminophen n=36 Participants Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen
Total Dose of Opioid	147.6 mcg/kg Interval 119.6 to 193.0	125.4 mcg/kg Interval 102.8 to 150.9

SECONDARY outcome

Timeframe: 24 hrs period following surgery

A secondary endpoint is the proportion of patients with pain scores in the severe pain range (7 or higher) on numeric pain rating scale of 0 to 10; higher score more severe.

Outcome measures

Measure	Oral Acetaminophen n=30 Participants Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen	Intravenous Acetaminophen n=36 Participants Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen
Proportion of Patients With Severe Pain Score of 7 or Higher	15 Participants	17 Participants

SECONDARY outcome

Timeframe: at the end of surgery, about 1 hour after IV Dose

Population: 2 patients in Oral did not have sample obtained for level; 1 patient in IV had value below 10 mg/L limit of quantification

mg/L acetaminophen in the plasma at the end of surgery

Outcome measures

Measure	Oral Acetaminophen n=28 Participants Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen	Intravenous Acetaminophen n=35 Participants Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen
Plasma Acetaminophen Level 1 - End of Surgery	22 mg/L Interval 16.5 to 27.8	20 mg/L Interval 17.0 to 22.0

SECONDARY outcome

Timeframe: Outcome will be measured 3hrs post first IV Dose

Population: Acetaminophen plasma levels obtained 3 hours after start of the IV study drug in patients with samples obtained; these were not available for 8 Oral and 9 IV subjects.

mg/L acetaminophen in the plasma 3 hours after IV study drug administration

Outcome measures

Measure	Oral Acetaminophen n=21 Participants Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision. Acetaminophen	Intravenous Acetaminophen n=16 Participants Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision. Acetaminophen
Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration	18 mg/L Interval 15.0 to 21.0	11 mg/L Interval 10.3 to 12.8

Adverse Events

Oral Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Acetaminophen

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

Richard L. Applegate II MD

UC Davis Anesthesiology & Pain Medicine

Phone: 916-734-5028

Email: rapplegate@ucdavis.edu

Results disclosure agreements

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