Cold Therapy for Pediatric Appendectomy

Appendicitis Clinical Trial

Official title:

Cold Therapy For Pain Control Among Pediatric Appendectomy Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986397
• Other study ID #: IRB-P00038266
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2021
• Est. completion date: October 2022

Study information

• Verified date: July 2022
• Source: Boston Children's Hospital
• Contact: Heung Bae Kim, MD
• Phone: 617-355-7800
• Email: Heung.Kim[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

Device:
• Cold Therapy
A Breg Polar Care Cube with WrapOn Polar Pad, Back will be filled with ice chips and water per manufacturer instructions and applied to the abdomen.

Other:
• Standard of Care
Standard post-operative analgesia without the use of cryotherapy.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

Cairo SB, Calabro KA, Bowdish E, Reilly C, Watt S, Rothstein DH. Variation in postoperative narcotic prescribing after pediatric appendectomy. J Pediatr Surg. 2019 Sep;54(9):1866-1871. doi: 10.1016/j.jpedsurg.2018.11.015. Epub 2019 Feb 7. — View Citation

Chumkam A, Pongrojpaw D, Chanthasenanont A, Pattaraarchachai J, Bhamarapravatana K, Suwannarurk K. Cryotherapy Reduced Postoperative Pain in Gynecologic Surgery: A Randomized Controlled Trial. Pain Res Treat. 2019 Mar 4;2019:2405159. doi: 10.1155/2019/2405159. eCollection 2019. — View Citation

Harbaugh CM, Gadepalli SK. Pediatric postoperative opioid prescribing and the opioid crisis. Curr Opin Pediatr. 2019 Jun;31(3):378-385. doi: 10.1097/MOP.0000000000000768. Review. — View Citation

Rentea RM, Peter SDS, Snyder CL. Pediatric appendicitis: state of the art review. Pediatr Surg Int. 2017 Mar;33(3):269-283. doi: 10.1007/s00383-016-3990-2. Epub 2016 Oct 14. Review. — View Citation

Watkins AA, Johnson TV, Shrewsberry AB, Nourparvar P, Madni T, Watkins CJ, Feingold PL, Kooby DA, Maithel SK, Staley CA, Master VA. Ice packs reduce postoperative midline incision pain and narcotic use: a randomized controlled trial. J Am Coll Surg. 2014 Sep;219(3):511-7. doi: 10.1016/j.jamcollsurg.2014.03.057. Epub 2014 May 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brief Pain Inventory Short Form	Pain diagram to indicate location of pain and 7 Likert-scale questions assessing pain severity and interference with feeling and function, scores ranging from 0 = No pain to 10 = pain as bad as you can imagine assessed just before hospital discharge and once daily.	Post operative days 1-3
Primary	Numeric Pain Intensity Scale	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.	Post operative days 1-3
Secondary	Mean Morphine Metabolic Equivalents (MME)	Mean amount of morphine administered throughout the duration of the hospital stay.	Limited to duration of hospital stay, up to 1 month
Secondary	Length of Hospital Stay	Length of time stayed in the hospital before being discharged	Duration of stay in hospital post-operatively, up to 1 month
Secondary	Time to Return of Tolerating Solid Food	Time in days it takes to tolerate solid foods.	Duration of time until beginning to tolerate solid food, up to 1 month