Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting

NCT02102555 | Terminated Phase 3

• 1 other identifier: MMC2013-25
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a single dose of IV acetaminophen can improve post-operative pain, nausea, and vomiting in the outpatient setting. Patient satisfaction, time to readiness of discharge, and the amount of opiates post operatively will also be measured.

Conditions

Post Operative Pain; Post Operative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting

  first postoperative day

Secondary Outcomes (3)

• postoperative nausea and vomiting (PONV)

  first postoperative day

• time until readiness of discharge

  first postoperative day

• IV analgesic consumption in recovery room

  first postoperative day

Study Arms (2)

IV acetaminophen

ACTIVE COMPARATOR

Patients in the IV acetaminophen arm will receive a one gram dose of IV acetaminophen in the pre-operative area prior to their surgery.

Drug: IV acetaminophen

Placebo

PLACEBO COMPARATOR

Patients in the placebo arm will receive normal saline in the pre-operative area.

Drug: placebo

Interventions

IV acetaminophen DRUG

Single dose of one gram of IV acetaminophen given in pre-operative area

Also known as: Ofirmev, paracetamol

IV acetaminophen

placebo DRUG

placebo (IV normal saline)

Placebo

Eligibility Criteria

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

You may qualify if:

• Each of the following must be met:
• Greater than or equal to 18 years of age.
• Female
• Undergoing outpatient breast surgery (unilateral or bilateral surgery)

You may not qualify if:

• If ANY of the following apply:
• History of an allergy or hypersensitivity to acetaminophen (oral, rectal, or IV)
• Chronic alcoholism
• Severe deficiency of liver and/or kidney
• Any patient unable to sign informed consent
• Pregnancy
• Any patient currently enrolled in another experimental protocol

Sponsors & Collaborators

• MercyOne Des Moines Medical Center: lead

Study Sites (1)

Mercy Medical Center-Des Moines

Des Moines, Iowa, 50314, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Vomiting

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Lauren D Allan, DO

  Mercy Medical Center-Des Moines General Surgery Residency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: April 3, 2014
• Study Start: October 1, 2013
• Primary Completion: May 3, 2017
• Study Completion: May 3, 2017
• Last Updated: January 14, 2020

Record last verified: 2019-08

Locations

US (1)