Cold Therapy for Pediatric Appendectomy

Study Overview
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Brief Summary
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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.

Official Title
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Cold Therapy For Pain Control Among Pediatric Appendectomy Patients: A Randomized Controlled Trial

Conditions
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Appendicitis

Intervention / Treatment
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* Device: Cold Therapy
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold Therapy & Standard Post Operative Analgesia<br>Patients in the cryotherapy group will have the ice water in their cryotherapy device maintained continuously for 2 days from initial application as this is the reported time of average patient disability and children typically return to school by post-operative day 3. The device will not be placed directly on the skin to minimize tissue damage. An additional protective barrier pad included with the cold therapy device will provide a barrier between the skin and the cooling device. This allows for continuous cooling at a higher target skin temperature. Aside from the cryotherapy, all surgical treatment will be standard of care. | Device: Cold Therapy<br>* 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.<br>* Other names: Cryotherapy;Other: Standard of Care<br>* Standard post-operative analgesia without the use of cryotherapy.<br>|
| Active Comparator: Standard Post Operative Analgesia<br> | Other: Standard of Care<br>* Standard post-operative analgesia without the use of cryotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post operative days 1-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Morphine Metabolic Equivalents (MME) | Mean amount of morphine administered throughout the duration of the hospital stay. | Limited to duration of hospital stay, up to 1 month | 
| Length of Hospital Stay | Length of time stayed in the hospital before being discharged | 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. | Duration of time until beginning to tolerate solid food, up to 1 month |