Non-melanoma Skin Cancer
Conditions
Keywords
Mohs micrographic surgery, pain, functional status
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.
Interventions
DRUGAcetaminophen
Acetaminophen 1000mg
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Pain Score | Day of surgery | Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hunger | Day of surgery | Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome. |
| Anxiety | Day of surgery | Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome. |
| Thirst | Day 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 Analgesic | 48 hours after surgery | Number of participants using over the counter and prescribed non-opioid and opioid pain medications |
| Maximum Post-op Pain Score | 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. |
| Fatigue | Day of surgery | Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome. |
Countries
United States
Participant flow
Pre-assignment details
No significant events during pre-assignment stage
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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 | 51 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 0 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 51 Participants | 96 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 12 | 65 years STANDARD_DEVIATION 10 | 65 years STANDARD_DEVIATION 10 |
| Pain scale | 3.4 units on a pain scale STANDARD_DEVIATION 1.5 | 1.3 units on a pain scale STANDARD_DEVIATION 0.6 | 1.7 units on a pain scale STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 51 Participants | 96 Participants |
| Region of Enrollment United States | 45 Participants | 51 Participants | 96 Participants |
| Sex: Female, Male Female | 18 Participants | 14 Participants | 32 Participants |
| Sex: Female, Male Male | 27 Participants | 37 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 45 | 0 / 51 |
| serious Total, serious adverse events | 0 / 45 | 0 / 51 |
Outcome results
Primary
Maximum Pain Score
Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Maximum Pain Score | 2.8 units on a pain scale | Standard Deviation 1.1 |
| Intervention | Maximum Pain Score | 1.2 units on a pain scale | Standard Deviation 0.6 |
Secondary
Anxiety
Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Anxiety | 7.6 score on an anxiety scale | Standard Deviation 16.7 |
| Intervention | Anxiety | 2.2 score on an anxiety scale | Standard Deviation 8.3 |
Secondary
Fatigue
Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Fatigue | 12 score on a fatigue scale | Standard Deviation 18 |
| Intervention | Fatigue | 10.7 score on a fatigue scale | Standard Deviation 18.4 |
Secondary
Hunger
Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Hunger | 19.9 units on a hunger scale | Standard Deviation 29.3 |
| Intervention | Hunger | 17.9 units on a hunger scale | Standard Deviation 28.3 |
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.
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Maximum Post-op Pain Score | 14 score on a maximum post-op scale | Standard Deviation 22.2 |
| Intervention | Maximum Post-op Pain Score | 13.6 score on a maximum post-op scale | Standard Deviation 20 |
Secondary
Number of Participants Using Post-operative Analgesic
Number of participants using over the counter and prescribed non-opioid and opioid pain medications
Time frame: 48 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants Using Post-operative Analgesic | 27 Participants |
| Intervention | Number of Participants Using Post-operative Analgesic | 34 Participants |
Secondary
Thirst
Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Time frame: Day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Thirst | 9.4 score on a thirst scale | Standard Deviation 18.7 |
| Intervention | Thirst | 10.5 score on a thirst scale | Standard Deviation 20.5 |