The overall aim of this study is to find out whether Hylenex recombinant (for short, Hylenex) in subcutaneous (SC) injection improves the speed and effectiveness of SC opioids in hospice patients. Specifically, this study proposes to compare the level of self-reported pain in hospice patients started on SC infusions of morphine and hydromorphone (Dilaudid) over the initial 8 hours of opioid infusion with and without the preceded co-injection of Hylenex. Hospice patients include both home-bound patients as well as those under intensive care in hospice houses.
As of January 2009, 58 patients were recruited to the study as study subjects. Target goals for the study is to recruit 88 subjects with full and accurate information with about 44 patients in the Hylenex group and another group of subjects in the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with or without the preceded co-injection of Hylenex. Hospice patients include both home-bound patients as well as those under intensive care in hospice houses.
Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.
Good Shepherd Hospice
Lakeland, Florida, United States
LifePath Hospice, Inc.
Tampa, Florida, United States
HPC Healthcare, Inc.
Temple Terrace, Florida, United States
The primary outcome measure will be the sum of 7 pain intensity differences (SPID) computed from 8 observations of pain during the 8-hour period.
Time frame: For a period of 8 hours from start to finish
The secondary outcome measure will be the sum of distress level differences (SDLD), sum of relief level differences (SRLD), and sum of bolus attempts (SBAM) made during the same 8-hour period.
Time frame: For a period of 8 hours from start to finish
The mean number of bolus attempts made over the 8-hour period between experimental and control groups.
Time frame: The bolus attempts will be observed for the 8-hour period from start to finish.
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