Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery

Chronic Sinusitis Clinical Trial

— IVAPAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608308
• Other study ID #: HSC-MS-12-0111
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: September 25, 2015
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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 :

1. by administering IV acetaminophen perioperatively (before start of surgery, and after surgery completion;

2. by employing a pain score of 4 (whereas other studies use 3) as a cutoff for breakthrough pain; and,

3. 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:

1. Pain

2. Rescue analgesic use

3. Nausea/Vomiting

4. Time spent in recovery

5. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 68 Years

Eligibility

Inclusion criteria:

1. Patients undergoing surgical management for CRS (with or without polyps)

2. Operating time must be at least 2 hours in duration.

3. Number of sinuses involved must be 3 or greater

Exclusion criteria:

1. History of hypersensitivity to acetaminophen

2. End stage renal disease

3. End stage liver disease

4. History of chronic pain, or use of opioid medication in the previous two weeks

5. Severe depression or anxiety

6. Use of gabapentin or any other pain modulator

7. History of acute sinusitis or mucocele

8. History of seizures

9. Known or suspected history of alcohol or drug abuse

10. Known or suspected history of morphine intolerance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• IV Acetaminophen
1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.
• Placebo
100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Locations

Country	Name	City	State
United States	The University of Texas Health Sciences Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	15 minutes and 120 minutes Post-Operatively	No
Secondary	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.	During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)	No
Secondary	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.	During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)	No
Secondary	Number of Participants Who Experienced Postoperative Morbidity (Nausea)	Post-operative nausea will be monitored and measured through direct observation and nursing clinical record	During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)	No
Secondary	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.	During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)	No
Secondary	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.	During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)	No
Secondary	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.	During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)	No
Secondary	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.	During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)	No
Secondary	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.	During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)	No