Preoperative Acetaminophen and Carbohydrate Loading

Non-melanoma Skin Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131713
• Other study ID #: 12136
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2019
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-melanoma Skin Cancer
• Skin Neoplasms

Intervention

Drug:
• Acetaminophen
Acetaminophen 1000mg

Locations

Country	Name	City	State
United States	Tufts Dermatology	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Thirst	Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome.	Day of surgery
Secondary	Hunger	Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome.	Day of surgery
Secondary	Anxiety	Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome.	Day of surgery
Secondary	Fatigue	Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome.	Day of surgery
Secondary	Number of Participants Using Post-operative Analgesic	Number of participants using over the counter and prescribed non-opioid and opioid pain medications	48 hours after surgery
Secondary	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.	48 hours after surgery