Cold Therapy for Pediatric Appendectomy

Not Applicable

• Conditions: Appendicitis
• Interventions: Other: Standard of Care; Device: Cold Therapy

• Registration Number: NCT04986397
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-02
• Study Start: 2021-12-22
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-01
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Post Operative Analgesia	Standard of Care	-
Cold Therapy & Standard Post Operative Analgesia	Standard of Care	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.
Cold Therapy & Standard Post Operative Analgesia	Cold Therapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States