Assessing Function in Pediatric Patients With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

Assessing Function in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain Using the FIM Instrument

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590148
• Other study ID #: 07-163
• Status: Completed
• Phase: N/A
• First received: December 27, 2007
• Last updated: July 29, 2013
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the FIM™ as a measure of daily function in children with sickle cell disease hospitalized with vasoocclusive pain. Currently, the standard for pain assessment is a rating of pain intensity, as determined by observation (for younger children) or self-report (for older children and adolescents). However, these measures of pain intensity are not effective in recurrent or chronic pain states, and in sickle cell disease in particular. Pediatric patients who are hospitalized with vasoocclusive pain often do not report a decrease in pain intensity; however, other indications of clinical status, such as ambulation, less use of opiates from the patient-controlled analgesia (PCA) pump, increased food intake, and transition to oral pain medication, signify that the patient may be improving. As a result of our inability to get an accurate picture of the patients' condition, we would like to have a summary of improvement that would reflect these changes in clinical status and reflect the reduced impact of sickle cell pain on the patient's life. In this study, we plan to evaluate a standardized functional assessment measure in pediatric patients with sickle cell disease. It is hypothesized that FIM™ scores will correlate with other indicators of clinical status, such as movement, quality of sleep, use of IV opiates from the patient-controlled analgesia (PCA) pump, and use of intravenous vs. oral pain medications. It is also hypothesized that the FIM™ will demonstrate adequate responsiveness to change in functional status within a 3-7 day hospitalization by a progressive increase in scores and associations with other indicators of clinical improvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 21 Years

Eligibility

Inclusion Criteria:

• Ages 7-21 years inclusive

• Documented sickle cell disease

• Sudden onset of pain consistent with vasoocclusive episode

• Pain requiring hospitalization and placement on standard clinical guideline for management of acute pain in sickle cell disease

• Cognitive ability to report pain on a 0-10 Numerical Rating Scale (NRS)

• Parental consent and child assent

Exclusion Criteria:

• Younger than 7 years old

• Primary diagnosis other than vasoocclusive pain

• Concurrent Acute Chest Syndrome (ACS)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FIM score		Daily	No
Secondary	Adolescent Pediatric Pain Tool (APPT) body outline score		Daily	No