Cold Therapy For Pain Control Among Pediatric Appendectomy Patients: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Numeric Pain Intensity Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cold Therapy & Standard Post Operative Analgesia
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.
Intervention: Standard of Care (Other)
Cold Therapy & Standard Post Operative Analgesia
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.
Intervention: Cold Therapy (Device)
Standard Post Operative Analgesia
Intervention: Standard of Care (Other)
Outcomes
Primary Outcomes
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
- Mean Morphine Metabolic Equivalents (MME)(Limited to duration of hospital stay, up to 1 month)
- Length of Hospital Stay(Duration of stay in hospital post-operatively, up to 1 month)
- Time to Return of Tolerating Solid Food(Duration of time until beginning to tolerate solid food, up to 1 month)
Investigators
Heung Bae Kim
Professor of Surgery
Boston Children's Hospital