Cold Therapy for Pediatric Appendectomy

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04986397

Enrollment

Registered

2021-08-02

Start date

2021-12-22

Completion date

2023-05-22

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis

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.

Interventions

DEVICECold 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.

OTHERStandard of Care

Standard post-operative analgesia without the use of cryotherapy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Numeric Pain Intensity Scale	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.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026