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A Comprehensive Care Plan for Pediatric Patients With Vaso-Occlusive Crises

NCT02698761 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-05-03

No results posted yet for this study

Summary

Sickle cell disease (SCD) is the most common inherited blood disorder affecting 80,000 to 90,000 individuals in the United States.\[10\] There are 13,000 hospital admissions for a sickle cell crises, costing $448 million dollars annually.\[10\] In our hospital, the sickle cell population is known to have some of the longest length of stays. Between October 2014 and September 2015, there were 89 admissions for a vaso-occlusive crisis with an average length of stay of 6 days and 12 admissions greater than 10 days and 5 admissions greater than 20 days.

We propose to evaluate the feasibility of the new CPP in a pilot randomized control trial to determine if pain and length of stay can be reduced in patients with sickle cell disease. We also propose to evaluate a sleep regimen to determine if this can reduce the hospital stay and help with pain. We hypothesize increased physical activity and proper sleep, as implemented in the CPP, are correlated with decreased hospital length of stay and decreased pain. Additionally, we believe that creating a standardized nighttime environment at the hospital will help the children stay in their circadian rhythm thus promoting improved sleep and a more effective inpatient disease management.

Conditions

Interventions

OTHER

Comprehensive Care Plan

Care Plan 1. Patient Controlled Analgesia (PCA). PCA will be initiated and managed at the discretion of the Pain Management team. 2. Other Medications. All medications will be given during daytime hours, if possible. 3. Pain Psychology. 4. Physical Therapy. Patient is expected to spend time out of bed by Day 2 participating in light activity. 5. Sleep Hygiene. Patient sleeps between the hours of 10 PM and 5 AM daily. Window blinds open by 8 AM. Patient must be awake and ready to participate in therapy by 9 AM. 6. Extracurricular. TV, phone, computer, and video games only between hours of 4-9 PM (computer okay outside of hours only for school work). 7. Other. Patient will eat meals during regular daytime hours (e.g. breakfast consumed before 9 am) and shower daily.

Sponsors & Collaborators

  • Phoenix Children's Hospital

    collaborator OTHER

  • Valley Anesthesiology Consultants

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02698761 on ClinicalTrials.gov