NCT02832687

Multi-dose Acetaminophen for Patients Undergoing General Anesthesia

Terminated Phase 4 Results posted Last updated 9 December 2021

What this trial tests

Phase 4 trial testing Acetaminophen in Recovery Following Cholecystectomy in 88 participants. Terminated before completion.

Timeline

19 June 2017

Primary endpoint
1 September 2020

31 December 2020

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	88
Start date	19 June 2017
Primary completion	1 September 2020
Estimated completion	31 December 2020
Sites	3 locations across United States

Drugs / interventions tested

• Acetaminophen (Paracetamol) — full drug profile →
• normal saline

Conditions studied

• Recovery Following Cholecystectomy — all drugs for Recovery Following Cholecystectomy →

Sponsor

Rutgers, The State University of New Jersey

Who can join

18 and older, any sex, with Recovery Following Cholecystectomy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Readiness for Discharge Primary · 2 hours following surgery

Number (percentage) of Participants with Readiness for Discharge (achieving discharge-readiness status at end of 2- hours post-surgery evaluated using the SPEEDs criteria: oxygen saturation, pain control, emesis control, extremity movement, dialogue, and stable vital signs.

Group	Value	95% CI
Normal Saline	26
Acetaminophen	33

Post Operative Pain Scores Secondary · Every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour

Pain scores every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour. Visual Analogue Scale (VAS) for pain was used: score on a scale from 0 (no pain) to 10 (worst pain) were recorded.

15 minutes

Group	Value	95% CI
Normal Saline	9	7 – 10
Acetaminophen	7	5 – 9

30 minutes

Group	Value	95% CI
Normal Saline	8	6 – 10
Acetaminophen	7	6 – 8

45 minutes

Group	Value	95% CI
Normal Saline	7	5 – 8
Acetaminophen	6	4 – 8

60 minutes

Group	Value	95% CI
Normal Saline	5	3 – 7
Acetaminophen	4	2 – 6

75 minutes

Group	Value	95% CI
Normal Saline	5	4 – 7
Acetaminophen	4	3 – 6

90 minutes

Group	Value	95% CI
Normal Saline	5	3 – 6
Acetaminophen	3	3 – 6

105 minutes

Group	Value	95% CI
Normal Saline	5	3 – 7
Acetaminophen	3	2 – 8

120 minutes

Group	Value	95% CI
Normal Saline	6.5	5 – 7
Acetaminophen	3	2 – 7

Plasma Stress Markers Secondary · Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU)

Concentration of the plasma stress markers including epinephrine, norepinephrine, cortisol, interleukins (IL) 6, 8 and 10.

Epinephrine After IV

Group	Value	95% CI
Normal Saline	48	34 – 91
Acetaminophen	65	42 – 87

Epinephrine In OR

Group	Value	95% CI
Normal Saline	42	24 – 52
Acetaminophen	58	37 – 108

Epinephrine 1h in PACU

Group	Value	95% CI
Normal Saline	152	81 – 255
Acetaminophen	128	82 – 184

Norepinephrine After IV

Group	Value	95% CI
Normal Saline	643	546 – 928
Acetaminophen	644	402 – 900

Norepinephrine In OR

Group	Value	95% CI
Normal Saline	532	350 – 665
Acetaminophen	547	341 – 872

Norepinephrine 1h in PACU

Group	Value	95% CI
Normal Saline	689	444 – 1054
Acetaminophen	884	533 – 1121

Cortisol After IV

Group	Value	95% CI
Normal Saline	50.5	30.2 – 76.8
Acetaminophen	54.6	29.9 – 75.8

Cortisol in OR

Group	Value	95% CI
Normal Saline	45.6	28.5 – 74.4
Acetaminophen	49	27.6 – 82.5

The Level of C-reactive Protein Secondary · Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU)

Concentration of the plasma C-reactive protein (CRP)

CRP after IV

Group	Value	95% CI
Normal Saline	1062.6	510.1 – 3741.4
Acetaminophen	1710.9	714.2 – 3536

CRP in OR

Group	Value	95% CI
Normal Saline	893.4	370.3 – 2336.4
Acetaminophen	1410.7	662.8 – 2943.2

CRP 1h in PACU

Group	Value	95% CI
Normal Saline	746.6	309 – 3861
Acetaminophen	1090.1	449.2 – 3461.5

Time to Rescue Pain Medication Secondary · From arrival in PACU to the first dose of pain medication is given during 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour.

Time to the first dose of pain medication

Group	Value	95% CI
Normal Saline	19	15 – 28
Acetaminophen	23	17 – 30

Total Dosage of Post Operative Opioids Secondary · From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour.

Total dosage of post operative opioids (hydromorphone)

Group	Value	95% CI
Normal Saline	1.2	1 – 1.6
Acetaminophen	1	0.6 – 1.6

Patient Satisfaction Survey Secondary · For patients going home the day of surgery the survey is given prior to departing the hospital (approx 5 hours post surgery). For those being admitted, the survey is given once discharge criteria are met in the PACU (approx 3 hours post surgery).

Survey asking patients about their satisfaction with the experience, pain control, and anesthetic rated on a 5 point Likert scale, with 1 being dissatisfied/unlikely and 5 being most satisfied/very likely. Subscales were summed to receive total score.

Group	Value	95% CI
Normal Saline	4	3 – 4
Acetaminophen	4	3 – 4

Number of Participants With Post Operative Nausea and Vomiting Secondary · From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour

Number of Participants with Post Operative Nausea and Vomiting

Group	Value	95% CI
Normal Saline	9
Acetaminophen	10

Number of Participants Requiring Additional Anti-emetics Secondary · From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour

Number of Participants Requiring Additional Anti-emetics (anti-vomiting)

Group	Value	95% CI
Normal Saline	8
Acetaminophen	7

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time patient sign Informed Consent Form for 24 hours or until discharge from the hospital, whatever comes first, an average of 12 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Normal Saline

Serious: 0/41 (0%)

Deaths: 0/41

Acetaminophen

Serious: 0/47 (0%)

Deaths: 0/47

Other adverse events (1 terms — click to expand)

Reaction	System	Normal Saline	Acetaminophen
Surgical complication	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT02832687 adverse events section.

Sponsor's own description

Study Objective The aim of the proposed study is to examine the effect of Q4 hour multidose IV acetaminophen on patients' readiness for discharge. In doing so the investigators will also investigate the various factors that could potentially contribute to a patient's readiness for discharge such as overall opioid consumption, time to rescue medication, incidence of postoperative nausea and vomiting, pain scores, and perioperative stress markers and their overall correlation with IV acetaminophen intake.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.