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Completed

NCT Number: NCT03131713

Preoperative Acetaminophen and Carbohydrate Loading

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tufts Dermatology

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

Acetaminophen 1000mg

Primary outcomes

  1. Maximum Pain Score

    Time frame: Day of surgery

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

Secondary outcomes

  1. Thirst

    Time frame: Day of surgery

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

  2. Hunger

    Time frame: Day of surgery

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

  3. Anxiety

    Time frame: Day of surgery

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

  4. Fatigue

    Time frame: Day of surgery

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

  5. Number of Participants Using Post-operative Analgesic

    Time frame: 48 hours after surgery

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

  6. Maximum Post-op Pain Score

    Time frame: 48 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2017
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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