Assessing Function in Pediatric Patients With Sickle Cell Disease

NCT ID: NCT00590148

Last Updated: 2013-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-12-31

Brief 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.

Conditions

Sickle Cell Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

William Zempsky, MD

Director, Pain Relief Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William T Zempsky, MD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Center

Locations

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

07-163

Identifier Type: -

Identifier Source: org_study_id