Post Operative PainPhase 3IVNCT02102555
Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting
A Phase 3 study testing IV acetaminophen in people with Post Operative Pain and Post Operative Nausea and Vomiting, run by MercyOne Des Moines Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Operative Pain, Post Operative Nausea and Vomiting
- What is being tested?
- IV acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 3 May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mercy Medical Center-Des Moines
Des Moines, Iowa, 50314
About this study
Official title: A Double-blind Randomized, Placebo-controlled Study to Determine the Effectiveness of Pre-operative IV Acetaminophen Administration in Reducing Post-operative Pain, Nausea, and Vomiting in the Outpatient Setting
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.
Read the detailed description
The purpose of this study is to determine if using a one time pre-operative dose of IV acetaminophen has an effect on post-operative nausea, vomiting, and pain. This is a randomized, double-blind, placebo-controlled prospective study on patients from the Katzmann Breast Center undergoing outpatient breast surgery (including excisional biopsy, lumpectomy, sentinel lymph node biopsy, axillary node dissection, or ductal excision).
IV acetaminophen (paracetamol) has been in Europe and other countries. In the U.S. the FDA approved IV acetaminophen (Ofirmev) in November of 2010. Since then, it has been used in many different ways, but most commonly in the first 24 hours post operative recovery period.
There will be two arms included in this study. Patients in Arm One will receive a one gram dose of IV acetaminophen in the pre-operative area. Patients in Arm Two will receive a dose of the placebo (IV normal saline). The medication will be disguised in the same bag as the normal saline, so no one (including the patient) in the pre-operative area will know which arm the patient is in. This prospective, randomized, double blind study will compare post-operative nausea, vomiting, and pain rates in patients from both arms.
The primary endpoint of this study will be to compare post-operative pain in patients receiving a pre-operative dose of IV acetaminophen to patients receiving the normal saline placebo. Secondary endpoints will include post-operative nausea and vomiting, recovery times, and overall satisfaction of pain management throughout their experience (assessed on post operative day one). If this study shows that IV acetaminophen given in the pre-operative setting decreases post-operative nausea, vomiting, and/or pain and/or shortens recovery time, and improves patient satisfaction in regards to their pain management, it could also become a routine medication given to all patients in the pre-operative setting.
- Being tested
- IV acetaminophen, placebo
- Medical subject headings
- Pain, Postoperative, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV acetaminophenDrug
Also called Ofirmev, paracetamol
Single dose of one gram of IV acetaminophen given in pre-operative area
placeboDrug
placebo (IV normal saline)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IV acetaminophen |
| Placebo | Placebo comparator | Patients in the placebo arm will receive normal saline in the pre-operative area. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting
Measured: first postoperative day
Secondary outcomes (3)
postoperative nausea and vomiting (PONV)
patient-rated postoperative nausea and vomiting (PONV) on visual analog scale
Measured: first postoperative day
time until readiness of discharge
time until readiness of discharge: measured from arrival to the recover room to discharge-order-written time (DOW time)
Measured: first postoperative day
IV analgesic consumption in recovery room
intravenous analgesic consumption in recovery room: converted to morphine-equivalents
Measured: first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startOct 2013
- Primary completion3 May 2017
- Study completion3 May 2017
Why it stopped: study closed due to difficulty enrolling subjects - no results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- MercyOne Des Moines Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren D Allan, DO, Principal investigator, Mercy Medical Center-Des Moines General Surgery Residency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102555
- Sponsor's protocol ID
- MMC2013-25
- Acronym
- IV
- Status last verified
- Aug 2019
- First submitted
- 31 Jan 2014
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized, Placebo-controlled Study to Determine the Effectiveness of Pre-operative IV Acetaminophen Administration in Reducing Post-operative Pain, Nausea, and Vomiting in the Outpatient Setting
- ClinicalTrials.gov ID
- NCT02102555
- Acronym / sponsor ID
- IV / MMC2013-25
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study closed due to difficulty enrolling subjects - no results
- Enrolment
- 82 participants (actual)
- Lead sponsor
- MercyOne Des Moines Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine if using a one time pre-operative dose of IV acetaminophen has an effect on post-operative nausea, vomiting, and pain. This is a randomized, double-blind, placebo-controlled prospective study on patients from the Katzmann Breast Center undergoing outpatient breast surgery (including excisional biopsy, lumpectomy, sentinel lymph node biopsy, axillary node dissection, or ductal excision).
IV acetaminophen (paracetamol) has been in Europe and other countries. In the U.S. the FDA approved IV acetaminophen (Ofirmev) in November of 2010. Since then, it has been used in many different ways, but most commonly in the first 24 hours post operative recovery period.
There will be two arms included in this study. Patients in Arm One will receive a one gram dose of IV acetaminophen in the pre-operative area. Patients in Arm Two will receive a dose of the placebo (IV normal saline). The medication will be disguised in the same bag as the normal saline, so no one (including the patient) in the pre-operative area will know which arm the patient is in. This prospective, randomized, double blind study will compare post-operative nausea, vomiting, and pain rates in patients from both arms.
The primary endpoint of this study will be to compare post-operative pain in patients receiving a pre-operative dose of IV acetaminophen to patients receiving the normal saline placebo. Secondary endpoints will include post-operative nausea and vomiting, recovery times, and overall satisfaction of pain management throughout their experience (assessed on post operative day one). If this study shows that IV acetaminophen given in the pre-operative setting decreases post-operative nausea, vomiting, and/or pain and/or shortens recovery time, and improves patient satisfaction in regards to their pain management, it could also become a routine medication given to all patients in the pre-operative setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV acetaminophen | Active comparator | Drug: IV acetaminophenPatients in the IV acetaminophen arm will receive a one gram dose of IV acetaminophen in the pre-operative area prior to their surgery. |
| Placebo | Placebo comparator | Drug: placeboPatients in the placebo arm will receive normal saline in the pre-operative area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than or equal to 18 years of age.
- Female
- Undergoing outpatient breast surgery (unilateral or bilateral surgery)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV acetaminophenAlso: Ofirmev, paracetamolSingle dose of one gram of IV acetaminophen given in pre-operative area | Drug | IV acetaminophen |
| placeboplacebo (IV normal saline) | Drug | Placebo |
Primary outcome
postoperative pain
Time frame: first postoperative day
postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting
3 secondary outcomes
postoperative nausea and vomiting (PONV)
Time frame: first postoperative day
time until readiness of discharge
Time frame: first postoperative day
IV analgesic consumption in recovery room
Time frame: first postoperative day
Results and safety
The study was stopped early (reason given: study closed due to difficulty enrolling subjects - no results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren D Allan, DO principal investigator
Mercy Medical Center-Des Moines General Surgery Residency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IV acetaminophen in people with Post Operative Pain and Post Operative Nausea and Vomiting, run by MercyOne Des Moines Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: study closed due to difficulty enrolling subjects - no results). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: first postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.