Preoperative IV Versus Oral Acetaminophen

Pain, Postoperative Clinical Trial

Official title:

Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468920
• Other study ID #: 17-114
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: April 12, 2019

Study information

• Verified date: May 2019
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.

Description:

This study will use a randomized, double-blind, controlled design with two arms:

Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively

120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 12, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or older

• Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia

Exclusion Criteria:

• Allergy to Acetaminophen

• Lactose intolerance or lactose allergy (placebo capsules contain lactose)

• Hepatic disease

• Having taken a product containing acetaminophen within 6 hours of scheduled surgery time

• Pregnant

• Weight less than 50kg

• Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse

• Emergent or on-call procedures

• Inpatient surgery

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• IV Acetaminophen
IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
• PO Acetaminophen
Acetaminophen PO 1000mg once pre-operatively
• PO Placebo
PO placebo capsule compounded to match PO Acetaminophen capsule
• IV Solution Placebo
This will serve as the placebo for the IV Acetaminophen intervention

Locations

Country	Name	City	State
United States	TriHealth, Bethesda Butler Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Reported Pain	Pain measured from 0 (no pain) to 10 (worst pain)	through study visit, less than 24 hours
Secondary	Number of Participants Who Received Opioid Administration in PACU	Number of Participants who Received Opioid Administration in PACU	through study visit, less than 24 hours
Secondary	Number of Participants Who Experienced Postoperative Nausea and Vomiting	Did patient experience negative effects of pain medication (postoperative nausea and vomiting)	through study visit, less than 24 hours
Secondary	Length of Stay	Minutes from entering PACU to end of Phase II	through study visit, less than 24 hours
Secondary	Patient Satisfaction	Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)	up to 2 days after surgery