Preoperative Acetaminophen and Carbohydrate Loading

NCT03131713 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 12136
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-melanoma Skin Cancer

Keywords

Mohs micrographic surgery; pain; functional status

Outcome Measures

Primary Outcomes (1)

• Maximum Pain Score

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

  Day of surgery

Secondary Outcomes (6)

• Thirst

  Day of surgery

• Hunger

  Day of surgery

• Anxiety

  Day of surgery

• Fatigue

  Day of surgery

• Number of Participants Using Post-operative Analgesic

  48 hours after surgery

Study Arms (2)

Control

NO INTERVENTION

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

EXPERIMENTAL

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.

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Acetaminophen 1000mg

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Dermatology

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Bichchau Nguyen, Principal Investigato
• Organization: Tufts Medical Center

bnguyen2@tuftsmedicalcenter.org

617-636-1286

Study Officials

• Bichchau Nguyen, M.D.

  Tufts Medical Center/Tufts University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: April 27, 2017
• Study Start: July 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 7, 2019
• Results First Posted: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)