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Cold Therapy for Pediatric Appendectomy
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
- 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
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
Find a Location
Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
788 Previous Clinical Trials
5,582,519 Total Patients Enrolled
2 Trials studying Appendicitis
15,000 Patients Enrolled for Appendicitis