Cold Therapy for Acute Appendicitis

N/A

Waitlist Available

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up limited to duration of hospital stay, up to 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a cold therapy device to see if it works better for children having their appendix removed. The device uses cold temperatures to help reduce pain and swelling after surgery. Researchers want to find out if this method is more effective.

Eligible Conditions

Acute Appendicitis
Appendicitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ limited to duration of hospital stay, up to 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~limited to duration of hospital stay, up to 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and limited to duration of hospital stay, up to 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Numeric Pain Intensity Scale

Secondary study objectives

Length of Hospital Stay

Mean Morphine Metabolic Equivalents (MME)

Time to Return of Tolerating Solid Food

Other study objectives

Brief Pain Inventory Short Form

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cold Therapy & Standard Post Operative AnalgesiaExperimental Treatment2 Interventions

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 II: Standard Post Operative AnalgesiaActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cold Therapy

2017

N/A

~40

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