Cold Therapy for Pediatric Appendectomy

Boston Children's Hospital

Status: Enrolling

Conditions: Appendicitis

Treatments: Device: Cold Therapy; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04986397

IRB-P00038266

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Cold Therapy & Standard Post Operative Analgesia

Experimental group

Description:

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.

Treatment:

Device: Cold Therapy

Other: Standard of Care

Standard Post Operative Analgesia

Active Comparator group

Treatment:

Other: Standard of Care