Cold Therapy for Pediatric Appendectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-22

Study Completion Date

2022-10-31

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.

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Detailed Description

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Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cold Therapy & Standard Post Operative Analgesia

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.

Group Type EXPERIMENTAL

Cold Therapy

Intervention Type DEVICE

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 of Care

Intervention Type OTHER

Standard post-operative analgesia without the use of cryotherapy.

Standard Post Operative Analgesia

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Standard post-operative analgesia without the use of cryotherapy.

Interventions

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Cold 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.

Intervention Type DEVICE

Standard of Care

Standard post-operative analgesia without the use of cryotherapy.

Intervention Type OTHER

Other Intervention Names

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Breg Polar Care Cube Cryotherapy

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

Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No