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Completed

NCT Number: NCT04986397

Cold Therapy for Pediatric Appendectomy

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.

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Key information

Conditions

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

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Breg Polar Care Cube, Cryotherapy

Standard of care

Other

Standard post-operative analgesia without the use of cryotherapy.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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