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Preoperative Acetaminophen and Carbohydrate Loading

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ClinicalTrials.gov Identifier: NCT03131713
Recruitment Status : Completed
First Posted : April 27, 2017
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-melanoma Skin Cancer Drug: Acetaminophen Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
No Intervention: Control
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.
Experimental: Intervention
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
Acetaminophen 1000mg




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131713


Locations
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United States, Massachusetts
Tufts Dermatology
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Bichchau Nguyen, M.D. Tufts Medical Center/Tufts University School of Medicine
  Study Documents (Full-Text)

Documents provided by Tufts Medical Center:

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03131713     History of Changes
Other Study ID Numbers: 12136
First Posted: April 27, 2017    Key Record Dates
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tufts Medical Center:
Mohs micrographic surgery
pain
functional status
Additional relevant MeSH terms:
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Acetaminophen
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics