This is a randomized control trial to evaluate the efficacy of an FDA approved cold therapy device vs. usual care among children undergoing appendectomy at a large children's hospital.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
52
A Breg Polar Care Cube with WrapOn Polar Pad, Back will be filled with ice chips and water per manufacturer instructions and applied to the abdomen.
Standard post-operative analgesia without the use of cryotherapy.
Boston Children's Hospital
Boston, Massachusetts, United States
Numeric Pain Intensity Scale
The primary outcome variable in this trial is pain score as reported on the Numeric Pain Intensity Scale. These scores will be self-reported (Numerical Pain Intensity Scale, 0-10 visual analog scale with 0 representing no pain and 10 representing the worst pain imaginable) assessed and documented once daily.
Time frame: Post operative days 1-3
Mean Morphine Metabolic Equivalents (MME)
Mean amount of morphine administered throughout the duration of the hospital stay.
Time frame: Limited to duration of hospital stay, up to 1 month
Length of Hospital Stay
Length of time stayed in the hospital before being discharged
Time frame: Duration of stay in hospital post-operatively, up to 1 month
Time to Return of Tolerating Solid Food
Time in days it takes to tolerate solid foods.
Time frame: Duration of time until beginning to tolerate solid food, up to 1 month
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