Trial Outcomes & Findings for Preoperative Acetaminophen and Carbohydrate Loading (NCT NCT03131713)
NCT ID: NCT03131713
Last Updated: 2019-10-07
Results Overview
Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Day of surgery
Results posted on
2019-10-07
Participant Flow
No significant events during pre-assignment stage
Participant milestones
| Measure |
Control
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
45
|
51
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Control
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
Baseline Characteristics
Preoperative Acetaminophen and Carbohydrate Loading
Baseline characteristics by cohort
| Measure |
Control
n=45 Participants
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
n=51 Participants
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12 • n=5 Participants
|
65 years
STANDARD_DEVIATION 10 • n=7 Participants
|
65 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Pain scale
|
3.4 units on a pain scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
1.3 units on a pain scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
1.7 units on a pain scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day of surgeryRated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Outcome measures
| Measure |
Control
n=45 Participants
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
n=51 Participants
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
|---|---|---|
|
Maximum Pain Score
|
2.8 units on a pain scale
Standard Deviation 1.1
|
1.2 units on a pain scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Day of surgeryRated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Outcome measures
| Measure |
Control
n=45 Participants
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
n=51 Participants
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
|---|---|---|
|
Thirst
|
9.4 score on a thirst scale
Standard Deviation 18.7
|
10.5 score on a thirst scale
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: Day of surgeryRated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Outcome measures
| Measure |
Control
n=45 Participants
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
n=51 Participants
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
|---|---|---|
|
Hunger
|
19.9 units on a hunger scale
Standard Deviation 29.3
|
17.9 units on a hunger scale
Standard Deviation 28.3
|
SECONDARY outcome
Timeframe: Day of surgeryRated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Outcome measures
| Measure |
Control
n=45 Participants
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
n=51 Participants
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
|---|---|---|
|
Anxiety
|
7.6 score on an anxiety scale
Standard Deviation 16.7
|
2.2 score on an anxiety scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Day of surgeryRated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Outcome measures
| Measure |
Control
n=45 Participants
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
n=51 Participants
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
|---|---|---|
|
Fatigue
|
12 score on a fatigue scale
Standard Deviation 18
|
10.7 score on a fatigue scale
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: 48 hours after surgeryNumber of participants using over the counter and prescribed non-opioid and opioid pain medications
Outcome measures
| Measure |
Control
n=45 Participants
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
n=51 Participants
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
|---|---|---|
|
Number of Participants Using Post-operative Analgesic
|
27 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 48 hours after surgeryRated on a maximum post-op pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Outcome measures
| Measure |
Control
n=45 Participants
The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request.
|
Intervention
n=51 Participants
The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.
Acetaminophen: Acetaminophen 1000mg
|
|---|---|---|
|
Maximum Post-op Pain Score
|
14 score on a maximum post-op scale
Standard Deviation 22.2
|
13.6 score on a maximum post-op scale
Standard Deviation 20
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bichchau Nguyen, Principal Investigato
Tufts Medical Center
Phone: 617-636-1286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place