Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Pain Management

In brief

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.

Key facts

Study ID

NCT00547664

Run by

HPC Healthcare, Inc.

People needed

88

Starts

2008-01-01

Expected to finish

2010-10-01

Last updated by the study team

2014-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-pregnant, non-lactating adults 18+ years enrolled in inpatient facilities at LifePath or Good Shepherd Hospice
• Ability to provide informed consent; Patient has decision-making capacity (SPMSQ score 6+)
• Ability to provide numerical report on pain level on pain scale
• English-speaking
• Pain not satisfactorily controlled with current meds -oral, topical, or rectal; Pain level greater than 3 at admission on a 0-10 scale
• Able to self-administer bolus dose or ask someone to hit bolus button
• Estimated life expectancy of 3 days or more
• Patients appropriate for continuous SC infusion with either morphine or hydromorphone.

You may not qualify if…

• History of allergy or hypersensitivity to Hylenex or any components of product
• Patients on infusion therapy for pain management up to 14 days prior to entering inpatient facilities.
• Patients who are actively dying identified by any of the following physical signs and symptoms:
• non-communicative or unresponsiveness; b) confusion/disorientation about time, place, and people; c) significant chest congestion with gurgling sounds; d) restless and repetitive motions; e) little or no food or fluid intake; f) minimal urine output and g) different breathing pattern, i.e., shallow rapid breaths with period of no breathing.

Where it is running

• Good Shepherd Hospice — Lakeland, Florida, United States
• LifePath Hospice, Inc. — Tampa, Florida, United States
• HPC Healthcare, Inc. — Temple Terrace, Florida, United States

Full record on ClinicalTrials.gov

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