Appendicitis
Conditions
Brief summary
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.
Interventions
DEVICECold Therapy
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.
OTHERStandard of Care
Standard post-operative analgesia without the use of cryotherapy.
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 7 years of older * Diagnosis of appendicitis and scheduled appendectomy
Exclusion criteria
* Neurologic and Decision Impairment * Chronic opioid dependency * Planned ICU admission post-operatively * Reoperation during hospital stay * Ward of the state * Non-english and non-spanish speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Intensity Scale | Post operative days 1-3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Duration of stay in hospital post-operatively, up to 1 month | Length of time stayed in the hospital before being discharged |
| Mean Morphine Metabolic Equivalents (MME) | Limited to duration of hospital stay, up to 1 month | Mean amount of morphine administered throughout the duration of the hospital stay. |
| Time to Return of Tolerating Solid Food | Duration of time until beginning to tolerate solid food, up to 1 month | Time in days it takes to tolerate solid foods. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Short Form | Post operative days 1-3 | Pain diagram to indicate location of pain and 7 Likert-scale questions assessing pain severity and interference with feeling and function, scores ranging from 0 = No pain to 10 = pain as bad as you can imagine assessed just before hospital discharge and once daily. |
Countries
United States
Contacts
Primary ContactHeung Bae Kim, MD
Backup ContactJonathan M Durgin, MD
Outcome results
None listed