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Preoperative Acetaminophen and Carbohydrate Loading

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ClinicalTrials.gov Identifier: NCT03131713
Recruitment Status : Completed
First Posted : April 27, 2017
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Non-melanoma Skin Cancer
Intervention Drug: Acetaminophen
Enrollment 101
Recruitment Details  
Pre-assignment Details No significant events during pre-assignment stage
Arm/Group Title Control Intervention
Hide Arm/Group Description 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.

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

Period Title: Overall Study
Started 50 51 [1]
Completed 45 51
Not Completed 5 0
Reason Not Completed
Lost to Follow-up             5             0
[1]
1 intervention subject was added on after the protocol was initiated.
Arm/Group Title Control Intervention Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 45 51 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 51 participants 96 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
45
 100.0%
51
 100.0%
96
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 51 participants 96 participants
65  (12) 65  (10) 65  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 51 participants 96 participants
Female
18
  40.0%
14
  27.5%
32
  33.3%
Male
27
  60.0%
37
  72.5%
64
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 51 participants 96 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
45
 100.0%
51
 100.0%
96
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 45 participants 51 participants 96 participants
45
 100.0%
51
 100.0%
96
 100.0%
Pain scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a pain scale
Number Analyzed 45 participants 51 participants 96 participants
3.4  (1.5) 1.3  (0.6) 1.7  (1.2)
[1]
Measure Description: Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
1.Primary Outcome
Title Maximum Pain Score
Hide Description Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 45 51
Mean (Standard Deviation)
Unit of Measure: units on a pain scale
2.8  (1.1) 1.2  (0.6)
2.Secondary Outcome
Title Thirst
Hide Description Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 45 51
Mean (Standard Deviation)
Unit of Measure: score on a thirst scale
9.4  (18.7) 10.5  (20.5)
3.Secondary Outcome
Title Hunger
Hide Description Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 45 51
Mean (Standard Deviation)
Unit of Measure: units on a hunger scale
19.9  (29.3) 17.9  (28.3)
4.Secondary Outcome
Title Anxiety
Hide Description Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 45 51
Mean (Standard Deviation)
Unit of Measure: score on an anxiety scale
7.6  (16.7) 2.2  (8.3)
5.Secondary Outcome
Title Fatigue
Hide Description Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 45 51
Mean (Standard Deviation)
Unit of Measure: score on a fatigue scale
12  (18) 10.7  (18.4)
6.Secondary Outcome
Title Number of Participants Using Post-operative Analgesic
Hide Description Number of participants using over the counter and prescribed non-opioid and opioid pain medications
Time Frame 48 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 45 51
Measure Type: Count of Participants
Unit of Measure: Participants
27
  60.0%
34
  66.7%
7.Secondary Outcome
Title Maximum Post-op Pain Score
Hide Description Rated on a maximum post-op pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame 48 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 45 51
Mean (Standard Deviation)
Unit of Measure: score on a maximum post-op scale
14  (22.2) 13.6  (20)
Time Frame 1 year
Adverse Event Reporting Description All-Cause Mortality was not monitored/assessed.
 
Arm/Group Title Control Intervention
Hide Arm/Group Description

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

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

All-Cause Mortality
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/51 (0.00%) 
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: Bichchau Nguyen, Principal Investigato
Organization: Tufts Medical Center
Phone: 617-636-1286
EMail: bnguyen2@tuftsmedicalcenter.org
Layout table for additonal information
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03131713     History of Changes
Other Study ID Numbers: 12136
First Submitted: March 6, 2017
First Posted: April 27, 2017
Results First Submitted: July 12, 2019
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019