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Cold Therapy for Appendicitis

N/A
Recruiting
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

Study Summary

This trial will compare the effects of an FDA approved cold therapy device versus usual care for children undergoing appendectomy at a large children's hospital.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric Pain Intensity Scale
Secondary outcome measures
Length of Hospital Stay
Mean Morphine Metabolic Equivalents (MME)
Time to Return of Tolerating Solid Food
Other outcome measures
Brief Pain Inventory Short Form

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
761 Previous Clinical Trials
5,579,678 Total Patients Enrolled
2 Trials studying Appendicitis
15,000 Patients Enrolled for Appendicitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of the American College of SurgeonsJournal
Ice Packs Reduce Postoperative Midline Incision Pain and Narcotic Use: A Randomized Controlled Trial
Watkins, Ammara A., Timothy V. Johnson, Adam B. Shrewsberry, Paymon Nourparvar, Tarik Madni, Colyn J. Watkins, Paul L. Feingold, et al.. 2014. “Ice Packs Reduce Postoperative Midline Incision Pain and Narcotic Use: A Randomized Controlled Trial”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jamcollsurg.2014.03.057.
Pain Research and TreatmentJournal
Cryotherapy Reduced Postoperative Pain in Gynecologic Surgery: A Randomized Controlled Trial
Chumkam, Apisada, Densak Pongrojpaw, Athita Chanthasenanont, Junya Pattaraarchachai, Kornkarn Bhamarapravatana, and Komsun Suwannarurk. 2019. “Cryotherapy Reduced Postoperative Pain in Gynecologic Surgery: A Randomized Controlled Trial”. Pain Research and Treatment. Hindawi Limited. doi:10.1155/2019/2405159.
Pediatric Surgery InternationalJournal
Pediatric Appendicitis: State of the Art Review
Rentea, Rebecca M., Shawn D. St. Peter, and Charles L. Snyder. 2016. “Pediatric Appendicitis: State of the Art Review”. Pediatric Surgery International. Springer Science and Business Media LLC. doi:10.1007/s00383-016-3990-2.
Journal of Pediatric SurgeryJournal
Variation in Postoperative Narcotic Prescribing After Pediatric Appendectomy
Cairo, Sarah B., Kristen A. Calabro, Elizabeth Bowdish, Cara Reilly, Stacey Watt, and David H. Rothstein. 2019. “Variation in Postoperative Narcotic Prescribing After Pediatric Appendectomy”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2018.11.015.
~16 spots leftby Apr 2025
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