Multi-dose Acetaminophen for Patients Undergoing General Anesthesia

NCT02832687 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 20150002613
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Recovery Following Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Readiness for Discharge

  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.

  2 hours following surgery

Secondary Outcomes (8)

• Post Operative Pain Scores

  Every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour

• Plasma Stress Markers

  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)

• The Level of C-reactive Protein

  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)

• Time to Rescue Pain Medication

  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.

• Total Dosage of Post Operative Opioids

  From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour.

Study Arms (2)

normal saline

ACTIVE COMPARATOR

Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist.

Drug: normal saline

acetaminophen

EXPERIMENTAL

Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients \<50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. \<50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours.

Also known as: Ofirmev

acetaminophen

normal saline DRUG

100mL of normal saline every 4 hours to a maximum administration of 400mL

Also known as: placebo

normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing ambulatory laparoscopic cholecystectomy.
• American Society of Anesthesiologists physical status 1, 2 or 3.-

You may not qualify if:

• Cognitively impaired (by history) and unable or unwilling to consent
• Chronic steroid or opioid user (as prescribed for a chronic systemic illness)
• Parturient or nursing mother. Patients who have been informed by a physician that they have liver or kidney disease

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Mallinckrodt: collaborator

Study Sites (3)

New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

University Hospital

Newark, New Jersey, 07103, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

MeSH Terms

Interventions

Acetaminophen; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Michal Gajewski, DO
• Organization: CHRISTUS St. Vincent Regional Medical Center

Michal.Gajewski@stvin.org

(505) 913-3361

Study Officials

• Michal Gajewski, Do

  Rutgers, State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: July 14, 2016
• Study Start: June 19, 2017
• Primary Completion: September 1, 2020
• Study Completion: December 31, 2020
• Last Updated: December 9, 2021
• Results First Posted: December 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)