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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Post Operative Analgesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Morphine Metabolic Equivalents (MME) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory Short Form | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27743024 | Background | 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. | |
| 30819545 | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 19, 2026 | Jun 15, 2026 | 8 |
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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|
| Standard of Care | Other | Standard post-operative analgesia without the use of cryotherapy. |
|
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 in days it takes to tolerate solid foods. | Duration of time until beginning to tolerate solid food, up to 1 month |
| 31090580 | 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. |
| 25081937 | 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. |
| 30949366 | 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. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |