Trial Outcomes & Findings for Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery (NCT NCT01608308)
NCT ID: NCT01608308
Last Updated: 2015-10-16
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
15 minutes and 120 minutes Post-Operatively
Results posted on
2015-10-16
Participant Flow
Recruitment is completed.
Participant milestones
| Measure |
IV Acetaminophen
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.
|
Control
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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
IV Acetaminophen
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.
|
Control
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.
|
|---|---|---|
|
Overall Study
pretreatment medical and billing reasons
|
0
|
2
|
Baseline Characteristics
Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery
Baseline characteristics by cohort
| Measure |
IV Acetaminophen
n=31 Participants
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.
|
Control
n=31 Participants
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
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
53.95 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes and 120 minutes Post-OperativelyPopulation: 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.
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).
Outcome measures
| Measure |
IV Acetaminophen
n=24 Participants
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.
|
Control
n=26 Participants
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.
|
|---|---|---|
|
Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale
15 minutes (n=24, 26)
|
0 units on a scale
Interval 0.0 to 3.0
|
0 units on a scale
Interval 0.0 to 4.0
|
|
Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale
120 minutes (n=7, 11)
|
0 units on a scale
Interval 0.0 to 2.0
|
2 units on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine.
Outcome measures
| Measure |
IV Acetaminophen
n=31 Participants
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.
|
Control
n=29 Participants
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 Doses of Postoperative Opiate (Morphine) Use
|
1.5 doses
Interval 1.0 to 2.5
|
2.5 doses
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)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.
Outcome measures
| Measure |
IV Acetaminophen
n=31 Participants
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.
|
Control
n=29 Participants
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.
|
|---|---|---|
|
Number of Participants Who Received Intraoperative Supplemental Fentanyl
|
9 participants
|
4 participants
|
SECONDARY outcome
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)Post-operative nausea will be monitored and measured through direct observation and nursing clinical record
Outcome measures
| Measure |
IV Acetaminophen
n=31 Participants
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.
|
Control
n=29 Participants
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.
|
|---|---|---|
|
Number of Participants Who Experienced Postoperative Morbidity (Nausea)
|
13 participants
|
10 participants
|
SECONDARY outcome
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)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.
Outcome measures
| Measure |
IV Acetaminophen
n=28 Participants
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.
|
Control
n=27 Participants
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.
|
|---|---|---|
|
Postoperative Vital Sign (Systolic Blood Pressure)
|
133 mmHg
Standard Deviation 17.2
|
144 mmHg
Standard Deviation 15
|
SECONDARY outcome
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)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.
Outcome measures
| Measure |
IV Acetaminophen
n=28 Participants
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.
|
Control
n=27 Participants
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.
|
|---|---|---|
|
Postoperative Vital Sign (Diastolic Blood Pressure)
|
75 mmHg
Standard Deviation 13.5
|
78.3 mmHg
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)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.
Outcome measures
| Measure |
IV Acetaminophen
n=29 Participants
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.
|
Control
n=27 Participants
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.
|
|---|---|---|
|
Postoperative Vital Sign (Pulse)
|
76.3 beats per minute
Standard Deviation 12.4
|
80 beats per minute
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)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.
Outcome measures
| Measure |
IV Acetaminophen
n=29 Participants
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.
|
Control
n=26 Participants
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.
|
|---|---|---|
|
Postoperative Vital Sign (Temperature)
|
97.1 Fahrenheit
Standard Deviation 0.8
|
97.4 Fahrenheit
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)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.
Outcome measures
| Measure |
IV Acetaminophen
n=31 Participants
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.
|
Control
n=29 Participants
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.
|
|---|---|---|
|
Postoperative Vital Sign (Respiratory Rate)
|
17.4 breaths per minute
Standard Deviation 1.2
|
17.2 breaths per minute
Standard Deviation 1.3
|
Adverse Events
IV Acetaminophen
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IV Acetaminophen
n=31 participants at risk
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.
|
Control
n=29 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Nausea
|
41.9%
13/31
|
34.5%
10/29
|
Additional Information
Davide Cattano
The University of Texas Health Science Center at Houston
Phone: (713) 500-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place