Cold Therapy for Pediatric Appendectomy

NCT04986397 | Completed FDA Device

• 1 other identifier: IRB-P00038266
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Morphine Metabolic Equivalents (MME)

  Limited to duration of hospital stay, up to 1 month

• Length of Hospital Stay

  Duration of stay in hospital post-operatively, up to 1 month

• Time to Return of Tolerating Solid Food

  Duration of time until beginning to tolerate solid food, up to 1 month

Other Outcomes (1)

• Brief Pain Inventory Short Form

  Post operative days 1-3

Study Arms (2)

Cold Therapy & Standard Post Operative Analgesia

EXPERIMENTAL

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.

Device: Cold Therapy; Other: Standard of Care

Standard Post Operative Analgesia

ACTIVE COMPARATOR

Other: Standard of Care

Interventions

Cold Therapy DEVICE

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.

Also known as: Breg Polar Care Cube, Cryotherapy

Cold Therapy & Standard Post Operative Analgesia

Standard of Care OTHER

Standard post-operative analgesia without the use of cryotherapy.

Cold Therapy & Standard Post Operative Analgesia; Standard Post Operative Analgesia

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 7 years of older
• Diagnosis of appendicitis and scheduled appendectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• 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.

  PMID: 27743024 BACKGROUND

• 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.

  PMID: 30819545 BACKGROUND

• 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.

  PMID: 31090580 BACKGROUND

• 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.

  PMID: 25081937 BACKGROUND

• 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.

  PMID: 30949366 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Cryotherapy; Standard of Care

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: August 2, 2021
• Study Start: December 22, 2021
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)