Chronic SinusitisIVAPAPNCT01608308
Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery
A study testing IV Acetaminophen in people with Chronic Sinusitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess the use of IV acetaminophen (Ofirmev) as a and safe and efficacious agent in reducing post-operative pain; we hypothesize that its use will reduce post-operative pain when compared to a control group using the visual analogue score (VAS) analog pain scoring system. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Chronic Sinusitis
- 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
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgical management for CRS (with or without polyps)
- Operating time must be at least 2 hours in duration.
- Number of sinuses involved must be 3 or greater
Who cannot join
- History of hypersensitivity to acetaminophen
- End stage renal disease
- End stage liver disease
- History of chronic pain, or use of opioid medication in the previous two weeks
- Severe depression or anxiety
- Use of gabapentin or any other pain modulator
Show all 10Show fewer
- History of acute sinusitis or mucocele
- History of seizures
- Known or suspected history of alcohol or drug abuse
- Known or suspected history of morphine intolerance
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
About this study
Official title: A Double Blind, Randomized, Placebo-controlled Study to Investigate the Effectiveness of IV Acetominophen Administered During Functional Endoscopic Sinus Surgery in Reducing the Use of Opiates to Treat Postoperative Pain
The purpose of this study is to assess the use of IV acetaminophen (Ofirmev) as a and safe and efficacious agent in reducing post-operative pain; we hypothesize that its use will reduce post-operative pain when compared to a control group using the visual analogue score (VAS) analog pain scoring system.
Read the detailed description
Unrelieved postoperative pain may result not only in suffering and discomfort, but may also lead to multiple physiological and psychological consequences which can contribute to adverse perioperative outcomes. Inadequate perioperative analgesia can potentially contribute to a higher incidence of myocardial ischemia. Additionally, the use of opioids has been associated with major side effects that can include impaired wound healing and delayed gastrointestinal (GI) motility that results in prolonged postoperative ileus.
Intravenous acetyl-para-aminophenol (APAP, also known as acetaminophen) is considered as the non-opioid analgesic of choice to treat postoperative mild and moderate pain, and has been demonstrated in several randomized trials to be both safe and effective at reducing acute post-operative pain in both children and adults. Furthermore, in the treatment of severe pain, it can reduce the need for opioid-analgesics while exhibiting a relatively limited side effect profile when compared to opioids and nonsteroidal anti-inflammatory drugs.
Chronic rhinosinusitis (CRS) describes a group of disorders characterized by inflammation of the nasal mucosa and/or paranasal sinuses for at least 12 consecutive weeks. In the United States, CRS affects approximately 30 million people, and represents 2% of the primary diagnoses in physician office visits, resulting in an estimated 200,000 sinus procedures annually. Patients suffering from CRS that is refractory to medical management complain of symptoms that include fatigue, headache, nasal drainage, facial pain and pressure, and decreased sense of smell. Functional endoscopic sinus surgery (FESS) represents a surgical approach to treating CRS that is unresponsive to medical management. Outcomes studies have identified FESS as efficacious at reducing the majority of symptoms related to CRS. Despite this, pain associated with CRS remains a significant co-morbidity that often is resistant to both medical and surgical management. Reducing the incidence and severity of acute post-operative pain is paramount to reducing the development of chronic pain that may exacerbate a patient's existing pain. The use of pre- and intra- operative IV acetaminophen thus serves as a unique pain management modality in this setting, as it has the potential for reducing post-operative complications and pain, with the additional benefit of minimal intraoperative bleeding, an undesirable complication often associated with FESS and with the use of non-steroidal anti-inflammatory drugs (NSAIDs).
The use of IV acetaminophen in ear, nose, and throat (ENT) surgery is not a novel endeavor. Indeed, studies have demonstrated the efficacy and safety of IV acetaminophen for use in tonsillectomy and FESS. We wish to provide a more comprehensive analysis of pain management in the setting of FESS in the following ways :
- by administering IV acetaminophen perioperatively (before start of surgery, and after surgery completion;
- by employing a pain score of 4 (whereas other studies use 3) as a cutoff for breakthrough pain; and,
- by addressing novel outcomes including patient sedation and patient satisfaction, in addition to opioid analgesic use.
In our institution, we have completed a preliminary pilot study exploring the use of intravenous anesthesia which included acetaminophen during bilateral endoscopic sinus surgery. Secondary outcomes measured during the study included:
- Pain
- Rescue analgesic use
- Nausea/Vomiting
- Time spent in recovery
- Successful discharge from the PACU and the Hospital
Our pilot data has reaffirmed that the procedure is overall benign, with few associated risks and adverse events. Of note, none of the patients in our preliminary study required admission to the hospital after surgery for further observation as a result of uncontrolled pain or nausea. Based on this experience, we would like to explore the efficacy of intravenous acetaminophen (Ofirmev), a non opioid/non steroidal analgesic, in endoscopic sinus surgery.
- Conditions
- Chronic Sinusitis
- Being tested
- IV Acetaminophen, Placebo
- Keywords
- Chronic Sinusitis, Pain Relief, Post-Operative Opioid Requirement, IV Acetaminophen, Functional Endoscopic Sinus Surgery, FESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
Also called OFIRMEV (Cadence Pharamceutical, San Diego, USA)
1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.
PlaceboDrug
Also called Normal Saline
100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.
| Study group | Role | What they receive |
|---|---|---|
| IV Acetaminophen | Experimental | The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations). Receives: Drug: IV Acetaminophen |
| Control | Placebo comparator | The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale
VAS is a validated, self-reported data sheet assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (highest level of pain).
Measured: 15 minutes and 120 minutes Post-Operatively
Secondary outcomes (8)
Total Doses of Postoperative Opiate (Morphine) Use
The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine.
Measured: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Number of Participants Who Received Intraoperative Supplemental Fentanyl
Number of participants who received intraoperative supplemental fentanyl. The decision to administer fentanyl is based on hemodynamic changes, such as increasing blood pressure and heart rate.
Measured: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Number of Participants Who Experienced Postoperative Morbidity (Nausea)
Post-operative nausea will be monitored and measured through direct observation and nursing clinical record
Measured: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Systolic Blood Pressure)
Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.
Measured: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Diastolic Blood Pressure)
Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.
Measured: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Pulse)
Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.
Measured: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Temperature)
Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.
Measured: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Respiratory Rate)
Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.
Measured: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, Davide Cattano, The University of Texas Health Science Center, Houston
- Investigators
- Davide Cattano, MD, PhD, Principal investigator, The University of Texas Health Sciences Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608308
- Sponsor's protocol ID
- HSC-MS-12-0111
- Acronym
- IVAPAP
- Status last verified
- Sep 2015
- First submitted
- 25 May 2012
- Last updated
- 16 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tyler MA, Lam K, Ashoori F, Cai C, Kain JJ, Fakhri S, Citardi MJ, Cattano D, Luong A. Analgesic Effects of Intravenous Acetaminophen vs Placebo for Endoscopic Sinus Surgery and Postoperative Pain: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Aug 1;143(8):788-794. doi: 10.1001/jamaoto.2017.0238.
PubMed 28542675
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo-controlled Study to Investigate the Effectiveness of IV Acetominophen Administered During Functional Endoscopic Sinus Surgery in Reducing the Use of Opiates to Treat Postoperative Pain
- ClinicalTrials.gov ID
- NCT01608308
- Acronym / sponsor ID
- IVAPAP / HSC-MS-12-0111
- Conditions
- Chronic Sinusitis
- Keywords
- Chronic Sinusitis, Pain Relief, Post-Operative Opioid Requirement, IV Acetaminophen, Functional Endoscopic Sinus Surgery, FESS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Posted 4 Sep 2015
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 assess the use of IV acetaminophen (Ofirmev) as a and safe and efficacious agent in reducing post-operative pain; we hypothesize that its use will reduce post-operative pain when compared to a control group using the visual analogue score (VAS) analog pain scoring system.
Detailed description
Unrelieved postoperative pain may result not only in suffering and discomfort, but may also lead to multiple physiological and psychological consequences which can contribute to adverse perioperative outcomes. Inadequate perioperative analgesia can potentially contribute to a higher incidence of myocardial ischemia. Additionally, the use of opioids has been associated with major side effects that can include impaired wound healing and delayed gastrointestinal (GI) motility that results in prolonged postoperative ileus.
Intravenous acetyl-para-aminophenol (APAP, also known as acetaminophen) is considered as the non-opioid analgesic of choice to treat postoperative mild and moderate pain, and has been demonstrated in several randomized trials to be both safe and effective at reducing acute post-operative pain in both children and adults. Furthermore, in the treatment of severe pain, it can reduce the need for opioid-analgesics while exhibiting a relatively limited side effect profile when compared to opioids and nonsteroidal anti-inflammatory drugs.
Chronic rhinosinusitis (CRS) describes a group of disorders characterized by inflammation of the nasal mucosa and/or paranasal sinuses for at least 12 consecutive weeks. In the United States, CRS affects approximately 30 million people, and represents 2% of the primary diagnoses in physician office visits, resulting in an estimated 200,000 sinus procedures annually. Patients suffering from CRS that is refractory to medical management complain of symptoms that include fatigue, headache, nasal drainage, facial pain and pressure, and decreased sense of smell. Functional endoscopic sinus surgery (FESS) represents a surgical approach to treating CRS that is unresponsive to medical management. Outcomes studies have identified FESS as efficacious at reducing the majority of symptoms related to CRS. Despite this, pain associated with CRS remains a significant co-morbidity that often is resistant to both medical and surgical management. Reducing the incidence and severity of acute post-operative pain is paramount to reducing the development of chronic pain that may exacerbate a patient's existing pain. The use of pre- and intra- operative IV acetaminophen thus serves as a unique pain management modality in this setting, as it has the potential for reducing post-operative complications and pain, with the additional benefit of minimal intraoperative bleeding, an undesirable complication often associated with FESS and with the use of non-steroidal anti-inflammatory drugs (NSAIDs).
The use of IV acetaminophen in ear, nose, and throat (ENT) surgery is not a novel endeavor. Indeed, studies have demonstrated the efficacy and safety of IV acetaminophen for use in tonsillectomy and FESS. We wish to provide a more comprehensive analysis of pain management in the setting of FESS in the following ways :
- by administering IV acetaminophen perioperatively (before start of surgery, and after surgery completion;
- by employing a pain score of 4 (whereas other studies use 3) as a cutoff for breakthrough pain; and,
- by addressing novel outcomes including patient sedation and patient satisfaction, in addition to opioid analgesic use.
In our institution, we have completed a preliminary pilot study exploring the use of intravenous anesthesia which included acetaminophen during bilateral endoscopic sinus surgery. Secondary outcomes measured during the study included:
- Pain
- Rescue analgesic use
- Nausea/Vomiting
- Time spent in recovery
- Successful discharge from the PACU and the Hospital
Our pilot data has reaffirmed that the procedure is overall benign, with few associated risks and adverse events. Of note, none of the patients in our preliminary study required admission to the hospital after surgery for further observation as a result of uncontrolled pain or nausea. Based on this experience, we would like to explore the efficacy of intravenous acetaminophen (Ofirmev), a non opioid/non steroidal analgesic, in endoscopic sinus surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Acetaminophen | Experimental | Drug: IV AcetaminophenThe experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations). |
| Control | Placebo comparator | Drug: PlaceboThe control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations). |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing surgical management for CRS (with or without polyps)
- Operating time must be at least 2 hours in duration.
- Number of sinuses involved must be 3 or greater
Key exclusion criteria (10 listed)
- History of hypersensitivity to acetaminophen
- End stage renal disease
- End stage liver disease
- History of chronic pain, or use of opioid medication in the previous two weeks
- Severe depression or anxiety
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 (Cadence Pharamceutical, San Diego, USA)1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses. | Drug | IV Acetaminophen |
| PlaceboAlso: Normal Saline100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen. | Drug | Control |
Primary outcome
Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale
Time frame: 15 minutes and 120 minutes Post-Operatively
VAS is a validated, self-reported data sheet assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (highest level of pain).
8 secondary outcomes
Total Doses of Postoperative Opiate (Morphine) Use
Time frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Number of Participants Who Received Intraoperative Supplemental Fentanyl
Time frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Number of Participants Who Experienced Postoperative Morbidity (Nausea)
Time frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Systolic Blood Pressure)
Time frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Diastolic Blood Pressure)
Time frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Pulse)
Time frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Temperature)
Time frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Postoperative Vital Sign (Respiratory Rate)
Time frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28542675Tyler MA, Lam K, Ashoori F, Cai C, Kain JJ, Fakhri S, Citardi MJ, Cattano D, Luong A. Analgesic Effects of Intravenous Acetaminophen vs Placebo for Endoscopic Sinus Surgery and Postoperative Pain: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Aug 1;143(8):788-794. doi: 10.1001/jamaoto.2017.0238.
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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.
Davide Cattano, MD, PhD principal investigator
The University of Texas Health Sciences Center at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV Acetaminophen in people with Chronic Sinusitis, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 16 Oct 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale (time frame: 15 minutes and 120 minutes Post-Operatively). 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 NCT01608308, which also lists 1 linked publication.
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 16 Oct 2015.