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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen 1000mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Pain Score | Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Thirst | Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Day of surgery |
| Hunger | Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bichchau Nguyen, M.D. | Tufts Medical Center/Tufts University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Dermatology | Boston | Massachusetts | 02111 | United States |
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No significant events during pre-assignment stage
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. Acetaminophen: Acetaminophen 1000mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Pain Score | Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Posted | Mean | Standard Deviation | units on a pain scale | Day of surgery |
|
1 year
All-Cause Mortality was not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. Acetaminophen: Acetaminophen 1000mg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bichchau Nguyen, Principal Investigato | Tufts Medical Center | 617-636-1286 | bnguyen2@tuftsmedicalcenter.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2019 | Sep 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Day of surgery |
| Anxiety | Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Day of surgery |
| Fatigue | Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Day of surgery |
| 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 |
| 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 |
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. Acetaminophen: Acetaminophen 1000mg |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Pain scale | Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Mean | Standard Deviation | units on a pain scale |
|
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| Secondary | Thirst | Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Posted | Mean | Standard Deviation | score on a thirst scale | Day of surgery |
|
|
|
| Secondary | Hunger | Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Posted | Mean | Standard Deviation | units on a hunger scale | Day of surgery |
|
|
|
| Secondary | Anxiety | Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Posted | Mean | Standard Deviation | score on an anxiety scale | Day of surgery |
|
|
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| Secondary | Fatigue | Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Posted | Mean | Standard Deviation | score on a fatigue scale | 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 | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score on a maximum post-op scale | 48 hours after surgery |
|
|
|
| 0 |
| 0 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | 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. Acetaminophen: Acetaminophen 1000mg | 0 | 0 | 0 | 51 | 0 | 51 |
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| Aniline Compounds |
| D000588 | Amines |