AcetaminophenPhase 3NCT03295214
Acetaminophen Given Per Os and Intravenous in Sinus Surgery
A Phase 3 study testing Acetaminophen in people with Acetaminophen, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The primary objective of this study is to investigate the Visual Analog Score (VAS) for pain within the post-operative setting and determine if there is a statistically significant difference between the VAS for PO or IV acetaminophen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetaminophen
- What is being tested?
- Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to Mar 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to participate
- Undergoing FESS surgery at Massachusetts Eye and Ear (MEE)
- Over the age of 18 during time of surgery
- Weighing over 50kg
Who cannot join
- Severe hepatic impairment or active liver disease
- Known hypersensitivity to acetaminophen or to any excipients in the intravenous formulation
- chronic opioid use
- chronic pain
- alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
Brendan McBrine, BS, 617-573-6815, brendan_mcbrine@meei.harvard.edu
About this study
Official title: A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous
The primary objective of this study is to investigate the Visual Analog Score (VAS) for pain within the post-operative setting and determine if there is a statistically significant difference between the VAS for PO or IV acetaminophen. It is expected that in doing so the investigators can produce the maximal amount of pain relief after surgery while making conscientious monetary decisions.
Read the detailed description
Functional Endoscopic Sinus Surgery (FESS) is one of the most common Ear Nose and Throat Surgeries done in the United States annually. This procedure can vary from intense to moderate pain and as such it is difficult to properly gauge and treat postoperative pain in these patients. Commonly used in these cases, opioid drugs are given to provide adequate analgesia, however higher opioid usage is observed to cause increased Post-Anesthesia Care Unit (PACU) stays, respiratory complications and Postoperative Nausea and Vomiting (PONV). Acetaminophen is commonly used as an adjunct in these circumstances because of its opioid sparing properties.
Acetaminophen is a synthetic nonopioid p-aminophenol derivative available over the counter. Its properties include analgesic and antipyretic qualities and it is listed on the world health organization's list of essential medicines. The potential risks include liver damage, skin reactions and drug interactions when used with blood thinners at high doses. Acetaminophen has been extensively researched, in vitro and in vivo studies have found the drug to be safe when used at proper doses. Recently intravenous use of acetaminophen has gained popularity due to ease of use and ability to be given intraoperatively. This form of acetaminophen, although convenient, is around sixty two times the cost of oral acetaminophen. Due to this increased cost it is imperative that the investigators compare the two routes of administration in order to determine if the additional cost is justified.
- Conditions
- Acetaminophen
- Being tested
- Acetaminophen
- Keywords
- Acetaminophen, Functional Endoscopic Sinus Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Acetaminophen given for pain relief
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen 975mg Per Os | Active comparator | 975mg of Acetaminophen given by mouth Receives: Drug: Acetaminophen |
| Acetaminophen 1000mg Intravenous | Active comparator | 1000mg of Acetaminophen given intravenously Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS for pain
First VAS pain score applied
Measured: 0-1 hour
Secondary outcomes (6)
Opioid Use
Postoperative opioid consumption for pain control
Measured: 24 hours
Time in PACU
Time required to be admitted and discharged home
Measured: 3-5 hours
VAS for pain
Second VAS pain score applied
Measured: 1-2 hours
VAS for pain
Third VAS pain score applied
Measured: 2-3 hours
VAS for pain
Last VAS pain score applied
Measured: 24 hours
PONV
Incidence of PONV
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start28 Mar 2018
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AcetaminophenStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luliu Fat, Massachusetts Eye and Ear Infirmary
- Investigators
- Iuliu Fat, MD, Principal investigator, MEEI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295214
- Sponsor's protocol ID
- 1098410
- Status last verified
- Apr 2019
- First submitted
- 21 Sep 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carroll NV, Miederhoff PA, Cox FM, Hirsch JD. Costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting. J Clin Anesth. 1994 Sep-Oct;6(5):364-9. doi: 10.1016/s0952-8180(05)80004-2.
PubMed 7986507DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6. doi: 10.1097/00000539-199801000-00020.
PubMed 9428860Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6.
PubMed 23220855
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous
- ClinicalTrials.gov ID
- NCT03295214
- Acronym / sponsor ID
- 1098410
- Conditions
- Acetaminophen
- Keywords
- Acetaminophen, Functional Endoscopic Sinus Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 27 Sep 2017 (actual)
- 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 primary objective of this study is to investigate the Visual Analog Score (VAS) for pain within the post-operative setting and determine if there is a statistically significant difference between the VAS for PO or IV acetaminophen. It is expected that in doing so the investigators can produce the maximal amount of pain relief after surgery while making conscientious monetary decisions.
Detailed description
Functional Endoscopic Sinus Surgery (FESS) is one of the most common Ear Nose and Throat Surgeries done in the United States annually. This procedure can vary from intense to moderate pain and as such it is difficult to properly gauge and treat postoperative pain in these patients. Commonly used in these cases, opioid drugs are given to provide adequate analgesia, however higher opioid usage is observed to cause increased Post-Anesthesia Care Unit (PACU) stays, respiratory complications and Postoperative Nausea and Vomiting (PONV). Acetaminophen is commonly used as an adjunct in these circumstances because of its opioid sparing properties.
Acetaminophen is a synthetic nonopioid p-aminophenol derivative available over the counter. Its properties include analgesic and antipyretic qualities and it is listed on the world health organization's list of essential medicines. The potential risks include liver damage, skin reactions and drug interactions when used with blood thinners at high doses. Acetaminophen has been extensively researched, in vitro and in vivo studies have found the drug to be safe when used at proper doses. Recently intravenous use of acetaminophen has gained popularity due to ease of use and ability to be given intraoperatively. This form of acetaminophen, although convenient, is around sixty two times the cost of oral acetaminophen. Due to this increased cost it is imperative that the investigators compare the two routes of administration in order to determine if the additional cost is justified.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen 975mg Per Os | Active comparator | Drug: Acetaminophen975mg of Acetaminophen given by mouth |
| Acetaminophen 1000mg Intravenous | Active comparator | Drug: Acetaminophen1000mg of Acetaminophen given intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willingness to participate
- Undergoing FESS surgery at Massachusetts Eye and Ear (MEE)
- Over the age of 18 during time of surgery
- Weighing over 50kg
Key exclusion criteria (5 listed)
- Severe hepatic impairment or active liver disease
- Known hypersensitivity to acetaminophen or to any excipients in the intravenous formulation
- chronic opioid use
- chronic pain
- alcohol or drug abuse
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 |
|---|---|---|
| AcetaminophenAcetaminophen given for pain relief | Drug | Acetaminophen 1000mg Intravenous, Acetaminophen 975mg Per Os |
Primary outcome
VAS for pain
Time frame: 0-1 hour
First VAS pain score applied
6 secondary outcomes
Opioid Use
Time frame: 24 hours
Time in PACU
Time frame: 3-5 hours
VAS for pain
Time frame: 1-2 hours
VAS for pain
Time frame: 2-3 hours
VAS for pain
Time frame: 24 hours
PONV
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Background: PubMed 7986507Carroll NV, Miederhoff PA, Cox FM, Hirsch JD. Costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting. J Clin Anesth. 1994 Sep-Oct;6(5):364-9. doi: 10.1016/s0952-8180(05)80004-2.
- Background: PubMed 9428860DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6. doi: 10.1097/00000539-199801000-00020.
- Background: PubMed 23220855Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6.
- Individual participant dataSharing planned: No
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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.
Iuliu Fat, MD principal investigator
MEEI
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 Acetaminophen in people with Acetaminophen, run by Massachusetts Eye and Ear Infirmary 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 5 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: status not confirmed, as of the sponsor's last update on 10 Apr 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Quinkert, PhD (6175734192, amy_quinkert@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS for pain (time frame: 0-1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295214, which also lists 3 linked publications.
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 10 Apr 2019; AzTrials last refreshed its copy on 27 Oct 2026.