search
Back to results

Preoperative Acetaminophen and Carbohydrate Loading

Primary Purpose

Non-melanoma Skin Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-melanoma Skin Cancer focused on measuring Mohs micrographic surgery, pain, functional status

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma)

Exclusion Criteria:

  • history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen

Sites / Locations

  • Tufts Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm 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.

Outcomes

Primary Outcome Measures

Maximum Pain Score
Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.

Secondary Outcome Measures

Thirst
Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Hunger
Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Anxiety
Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Fatigue
Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Number of Participants Using Post-operative Analgesic
Number of participants using over the counter and prescribed non-opioid and opioid pain medications
Maximum Post-op Pain Score
Rated on a maximum post-op pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.

Full Information

First Posted
March 6, 2017
Last Updated
October 4, 2019
Sponsor
Tufts Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03131713
Brief Title
Preoperative Acetaminophen and Carbohydrate Loading
Official Title
Impact of Preoperative Acetaminophen and Carbohydrate Loading to on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Non-melanoma Skin Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate drinks on pain and functional status experienced by patients undergoing Mohs micrographic surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger, fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage of over the counter or prescribed pain medications, and presence of complications e.g. bleeding, infection, dehiscence. Differences in perioperative functional status and pain medication usage are compared between patients in control and intervention groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-melanoma Skin Cancer
Keywords
Mohs micrographic surgery, pain, functional status

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Acetaminophen 1000mg
Primary Outcome Measure Information:
Title
Maximum Pain Score
Description
Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame
Day of surgery
Secondary Outcome Measure Information:
Title
Thirst
Description
Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame
Day of surgery
Title
Hunger
Description
Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame
Day of surgery
Title
Anxiety
Description
Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame
Day of surgery
Title
Fatigue
Description
Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time Frame
Day of surgery
Title
Number of Participants Using Post-operative Analgesic
Description
Number of participants using over the counter and prescribed non-opioid and opioid pain medications
Time Frame
48 hours after surgery
Title
Maximum Post-op Pain Score
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma) Exclusion Criteria: history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bichchau Nguyen, M.D.
Organizational Affiliation
Tufts Medical Center/Tufts University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Dermatology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preoperative Acetaminophen and Carbohydrate Loading

We'll reach out to this number within 24 hrs