MedPath

Determine the Clinical Advantage of IV vs PO Acetaminophen

Phase 4
Completed
Conditions
Inguinal Hernia
Interventions
Registration Number
NCT03558555
Lead Sponsor
Yan Lai
Brief Summary

There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.

Detailed Description

In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
103
Inclusion Criteria
  • ASA scores I-III
  • Ambulatory surgery patients
  • Ages 18-75
  • Surgeries requiring general anesthesia for hernia surgery
Exclusion Criteria
  • Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
  • Known allergy to acetaminophen
  • Emergency surgery
  • Patients who were not fasted
  • Patients who cannot tolerate PO
  • Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
  • Pregnancy
  • Weight less than 50kg
  • Chronic daily narcotic use
  • Patients who's anesthetic plan requires regional anesthesia
  • Patient refusal to participate or do not have capacity to provide consent.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Oral AcetaminophenOral AcetaminophenPatients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.
Oral AcetaminophenSalinePatients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.
Acetaminophen IV SolnAcetaminophen IV SolnPatients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.
Acetaminophen IV SolnPlacebo PillsPatients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.
Primary Outcome Measures
NameTimeMethod
PACU Visual Analogue Pain Scoresbaseline, 1 hour, and Day 1 discharge

Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.

Total MME IntraoperativelyDay 1

Total Morphine Milligram Equivalent (MME) use intraoperatively

Total Narcotic Use in PACU.Day 1

Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)

Secondary Outcome Measures
NameTimeMethod
PACU Length of Stayup to 24 hours after PACU arrival

Time in PACU

Patient Satisfaction.7 days post surgery

Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction

Patient Reported Total Narcotic Use Post-dischargeaverage 7 days

home opiod use

Trial Locations

Locations (1)

Mount Sinai West Hospital

🇺🇸

New York, New York, United States

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