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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01608308
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : September 4, 2015
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Davide Cattano, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Chronic Sinusitis
Interventions Drug: IV Acetaminophen
Drug: Placebo
Enrollment 62
Recruitment Details Recruitment is completed.
Pre-assignment Details  
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description

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 acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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 acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Period Title: Overall Study
Started 31 31
Completed 31 29
Not Completed 0 2
Reason Not Completed
pretreatment medical and billing reasons             0             2
Arm/Group Title IV Acetaminophen Control Total
Hide Arm/Group Description

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Total of all reporting groups
Overall Number of Baseline Participants 31 31 62
Hide Baseline Analysis Population Description
In total 62 subjects were enrolled. Two subjects were dropped due to pretrreatment medical and billing issues;therefore, in total 60 subjects were dosed.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 62 participants
53.7  (14.6) 54.2  (14.4) 53.95  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Female
9
  29.0%
17
  54.8%
26
  41.9%
Male
22
  71.0%
14
  45.2%
36
  58.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 31 participants 62 participants
31 31 62
1.Primary Outcome
Title Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale
Hide Description 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).
Time Frame 15 minutes and 120 minutes Post-Operatively
Hide Outcome Measure Data
Hide Analysis Population Description
At the 15 minute time point, data was obtained for 24 participants in the acetaminophen group and 26 participants in the control group. For the 120 minute time point, data was obtained for 7 participants in the acetaminophen group and 11 participants in the control group.
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description:

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Overall Number of Participants Analyzed 24 26
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
15 minutes (n=24, 26)
0
(0 to 3)
0
(0 to 4)
120 minutes (n=7, 11)
0
(0 to 2)
2
(0 to 4)
2.Secondary Outcome
Title Total Doses of Postoperative Opiate (Morphine) Use
Hide Description The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine.
Time Frame During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description:

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Overall Number of Participants Analyzed 31 29
Median (Inter-Quartile Range)
Unit of Measure: doses
1.5
(1 to 2.5)
2.5
(2 to 4)
3.Secondary Outcome
Title Number of Participants Who Received Intraoperative Supplemental Fentanyl
Hide Description 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.
Time Frame During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description:

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Overall Number of Participants Analyzed 31 29
Measure Type: Number
Unit of Measure: participants
9 4
4.Secondary Outcome
Title Number of Participants Who Experienced Postoperative Morbidity (Nausea)
Hide Description Post-operative nausea will be monitored and measured through direct observation and nursing clinical record
Time Frame During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description:

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Overall Number of Participants Analyzed 31 29
Measure Type: Number
Unit of Measure: participants
13 10
5.Secondary Outcome
Title Postoperative Vital Sign (Systolic Blood Pressure)
Hide Description 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.
Time Frame During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description:

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: mmHg
133  (17.2) 144  (15)
6.Secondary Outcome
Title Postoperative Vital Sign (Diastolic Blood Pressure)
Hide Description 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.
Time Frame During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description:

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Overall Number of Participants Analyzed 28 27
Mean (Standard Deviation)
Unit of Measure: mmHg
75  (13.5) 78.3  (10.5)
7.Secondary Outcome
Title Postoperative Vital Sign (Pulse)
Hide Description 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.
Time Frame During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description:

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Overall Number of Participants Analyzed 29 27
Mean (Standard Deviation)
Unit of Measure: beats per minute
76.3  (12.4) 80  (13.2)
8.Secondary Outcome
Title Postoperative Vital Sign (Temperature)
Hide Description 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.
Time Frame During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description:

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Overall Number of Participants Analyzed 29 26
Mean (Standard Deviation)
Unit of Measure: Fahrenheit
97.1  (0.8) 97.4  (0.8)
9.Secondary Outcome
Title Postoperative Vital Sign (Respiratory Rate)
Hide Description 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.
Time Frame During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description:

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Overall Number of Participants Analyzed 31 29
Mean (Standard Deviation)
Unit of Measure: breaths per minute
17.4  (1.2) 17.2  (1.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Acetaminophen Control
Hide Arm/Group Description

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).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

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).

Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

All-Cause Mortality
IV Acetaminophen Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
IV Acetaminophen Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/29 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Acetaminophen Control
Affected / at Risk (%) Affected / at Risk (%)
Total   13/31 (41.94%)   10/29 (34.48%) 
Surgical and medical procedures     
Nausea   13/31 (41.94%)  10/29 (34.48%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Davide Cattano
Organization: The University of Texas Health Science Center at Houston
Phone: (713) 500-6200
EMail: Davide.Cattano@uth.tmc.edu
Layout table for additonal information
Responsible Party: Davide Cattano, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01608308    
Other Study ID Numbers: HSC-MS-12-0111
First Submitted: May 25, 2012
First Posted: May 31, 2012
Results First Submitted: June 12, 2015
Results First Posted: September 4, 2015
Last Update Posted: October 16, 2015