Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

HPC Healthcare

Status

Completed

Conditions

Pain Management

Treatments

Drug: Hylenex recombinant , morphine, saline

Other: Saline

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00547664

HPC200710

Details and patient eligibility

About

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.

Full description

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.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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:
1. 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.