Back to resultsCold Therapy for Pediatric Appendectomy
Primary Purpose
Appendicitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold Therapy
Standard of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Appendicitis
Eligibility Criteria
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
Sites / Locations
- Boston Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cold Therapy & Standard Post Operative Analgesia
Standard Post Operative Analgesia
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean Morphine Metabolic Equivalents (MME)
Mean amount of morphine administered throughout the duration of the hospital stay.
Length of Hospital Stay
Length of time stayed in the hospital before being discharged
Time to Return of Tolerating Solid Food
Time in days it takes to tolerate solid foods.
Full Information
NCT ID
NCT04986397
First Posted
June 15, 2021
Last Updated
July 29, 2022
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04986397
Brief Title
Cold Therapy for Pediatric Appendectomy
Official Title
Cold Therapy For Pain Control Among Pediatric Appendectomy Patients: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cold Therapy & Standard Post Operative Analgesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Post Operative Analgesia
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Cold Therapy
Other Intervention Name(s)
Breg Polar Care Cube, Cryotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard post-operative analgesia without the use of cryotherapy.
Primary Outcome Measure Information:
Title
Numeric Pain Intensity Scale
Description
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.
Time Frame
Post operative days 1-3
Secondary Outcome Measure Information:
Title
Mean Morphine Metabolic Equivalents (MME)
Description
Mean amount of morphine administered throughout the duration of the hospital stay.
Time Frame
Limited to duration of hospital stay, up to 1 month
Title
Length of Hospital Stay
Description
Length of time stayed in the hospital before being discharged
Time Frame
Duration of stay in hospital post-operatively, up to 1 month
Title
Time to Return of Tolerating Solid Food
Description
Time in days it takes to tolerate solid foods.
Time Frame
Duration of time until beginning to tolerate solid food, up to 1 month
Other Pre-specified Outcome Measures:
Title
Brief Pain Inventory Short Form
Description
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.
Time Frame
Post operative days 1-3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heung Bae Kim, MD
Phone
617-355-7800
Email
Heung.Kim@childrens.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan M Durgin, MD
Phone
617-355-7800
Email
jonathan.durgin@childrens.harvard.edu
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan M Durgin, MD
Phone
508-355-7800
Email
jonathan.durgin@childrens.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27743024
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.
Results Reference
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PubMed Identifier
30819545
Citation
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.
Results Reference
background
PubMed Identifier
31090580
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.
Results Reference
background
PubMed Identifier
25081937
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.
Results Reference
background
PubMed Identifier
30949366
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.
Results Reference
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Cold Therapy for Pediatric Appendectomy
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