Determine the Clinical Advantage of IV vs PO Acetaminophen

Yan Lai

Status and phase: Completed; Phase 4

Conditions: Inguinal Hernia

Treatments: Drug: Acetaminophen IV Soln; Drug: Saline; Drug: Oral Acetaminophen; Drug: Placebo Pills

Study type: Interventional

Funder types: Other

Identifiers

NCT03558555

IF#2175834 (Other Identifier)

IF#16-1763 (Other Identifier)

GCO 16-1763

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 2 patient groups

Oral Acetaminophen

Active Comparator group

Description:

Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.

Treatment:

Drug: Oral Acetaminophen

Drug: Saline

Acetaminophen IV Soln

Active Comparator group

Description:

Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.

Treatment:

Drug: Placebo Pills

Drug: Acetaminophen IV Soln