AppendicitisNCT04986397
Cold Therapy for Pediatric Appendectomy
A study testing Cold Therapy in people with Appendicitis, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- Cold Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2021to 22 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age of 7 years of older
- Diagnosis of appendicitis and scheduled appendectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Conditions
- Appendicitis
- Being tested
- Cold Therapy, Standard of Care
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold TherapyDevice
Also called Breg Polar Care Cube, Cryotherapy
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.
Standard of CareOther
Standard post-operative analgesia without the use of cryotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cold Therapy; Other: Standard of Care |
| Standard Post Operative Analgesia | Active comparator | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post operative days 1-3
Secondary outcomes (3)
Mean Morphine Metabolic Equivalents (MME)
Mean amount of morphine administered throughout the duration of the hospital stay.
Measured: Limited to duration of hospital stay, up to 1 month
Length of Hospital Stay
Length of time stayed in the hospital before being discharged
Measured: 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.
Measured: Duration of time until beginning to tolerate solid food, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start22 Dec 2021
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heung Bae Kim, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986397
- Sponsor's protocol ID
- IRB-P00038266
- Status last verified
- Apr 2026
- First submitted
- 15 Jun 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27743024Cairo 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.
PubMed 30819545Harbaugh 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.
PubMed 31090580Watkins 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.
PubMed 25081937Chumkam 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.
PubMed 30949366
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Therapy For Pain Control Among Pediatric Appendectomy Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04986397
- Acronym / sponsor ID
- IRB-P00038266
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Therapy & Standard Post Operative Analgesia | Experimental | Device: Cold Therapy, Other: Standard of CarePatients 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 | Other: Standard of Care |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age of 7 years of older
- Diagnosis of appendicitis and scheduled appendectomy
Key exclusion criteria (6 listed)
- Neurologic and Decision Impairment
- Chronic opioid dependency
- Planned ICU admission post-operatively
- Reoperation during hospital stay
- Ward of the state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold TherapyAlso: Breg Polar Care Cube, CryotherapyA 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. | Device | Cold Therapy & Standard Post Operative Analgesia |
| Standard of CareStandard post-operative analgesia without the use of cryotherapy. | Other | Cold Therapy & Standard Post Operative Analgesia, Standard Post Operative Analgesia |
Primary outcome
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.
3 secondary outcomes
Mean Morphine Metabolic Equivalents (MME)
Time frame: 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
Time to Return of Tolerating Solid Food
Time frame: Duration of time until beginning to tolerate solid food, up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 27743024Rentea 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.
- Background: PubMed 30819545Cairo 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.
- Background: PubMed 31090580Harbaugh 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.
- Background: PubMed 25081937Watkins 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.
- Background: PubMed 30949366Chumkam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Therapy in people with Appendicitis, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Intensity Scale (time frame: Post operative days 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04986397, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.