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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
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE April 27, 2017
Last Update Posted Date February 6, 2018
Actual Study Start Date  ICMJE July 1, 2016
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Maximum pain score [ Time Frame: Day of surgery ]
Rated on a scale of 0-100
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03131713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
  • thirst [ Time Frame: Day of surgery ]
    Rated on a scale of 0-100
  • hunger [ Time Frame: Day of surgery ]
    Rated on a scale of 0-100
  • anxiety [ Time Frame: Day of surgery ]
    Rated on a scale of 0-100
  • fatigue [ Time Frame: Day of surgery ]
    Rated on a scale of 0-100
  • Use of post-operative analgesic [ Time Frame: 48 hours after surgery ]
    Use of over the counter and prescribed non-opioid and opioid pain medications
  • Maximum post-op pain score [ Time Frame: 48 hours after surgery ]
    Rated on a scale of 0-100
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Acetaminophen and Carbohydrate Loading
Official Title  ICMJE Impact of Preoperative Acetaminophen and Carbohydrate Loading to on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Non-melanoma Skin Cancers
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Non-melanoma Skin Cancer
Intervention  ICMJE Drug: Acetaminophen
Acetaminophen 1000mg
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Acetaminophen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03131713
Other Study ID Numbers  ICMJE 12136
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tufts Medical Center
Study Sponsor  ICMJE Tufts Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bichchau Nguyen, M.D. Tufts Medical Center/Tufts University School of Medicine
PRS Account Tufts Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP