Cold Therapy for Pediatric Appendectomy

April 23, 2026 updated by: Heung Bae Kim, Boston Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold Therapy & Standard Post Operative Analgesia
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
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 Names:
  • Cryotherapy
  • Breg Polar Care Cube
Other: Standard of Care
Standard post-operative analgesia without the use of cryotherapy.
Active Comparator: Standard Post Operative Analgesia
Other: Standard of Care
Standard post-operative analgesia without the use of cryotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Intensity Scale
Time Frame: Post operative days 1-3
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Morphine Metabolic Equivalents (MME)
Time Frame: Limited to duration of hospital stay, up to 1 month
Mean amount of morphine administered throughout the duration of the hospital stay.
Limited to duration of hospital stay, up to 1 month
Length of Hospital Stay
Time Frame: Duration of stay in hospital post-operatively, up to 1 month
Length of time stayed in the hospital before being discharged
Duration of stay in hospital post-operatively, up to 1 month
Time to Return of Tolerating Solid Food
Time Frame: Duration of time until beginning to tolerate solid food, up to 1 month
Time in days it takes to tolerate solid foods.
Duration of time until beginning to tolerate solid food, up to 1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory Short Form
Time Frame: Post operative days 1-3
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2021

Primary Completion (Actual)

May 22, 2023

Study Completion (Actual)

May 22, 2023

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00038266

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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