MedPath

Preoperative Acetaminophen and Carbohydrate Loading

Phase 3
Completed
Conditions
Non-melanoma Skin Cancer
Interventions
Registration Number
NCT03131713
Lead Sponsor
Tufts Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
101
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionAcetaminophenThe 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.
Primary Outcome Measures
NameTimeMethod
Maximum Pain ScoreDay of surgery

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

Secondary Outcome Measures
NameTimeMethod
AnxietyDay of surgery

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

ThirstDay of surgery

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

Number of Participants Using Post-operative Analgesic48 hours after surgery

Number of participants using over the counter and prescribed non-opioid and opioid pain medications

HungerDay of surgery

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

FatigueDay of surgery

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

Maximum Post-op Pain Score48 hours after surgery

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

Trial Locations

Locations (1)

Tufts Dermatology

🇺🇸

Boston, Massachusetts, United States

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