Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Pain Management

Intervention / Treatment
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* Drug: Hylenex recombinant , morphine, saline
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Hylenex recombinant , morphine, saline<br>* 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.<br>* Other names: hyaluronidase human injection;|
| Placebo Comparator: B<br> | Drug: Hylenex recombinant , morphine, saline<br>* 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.<br>* Other names: hyaluronidase human injection;Other: Saline<br>* Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.<br>* Other names: Saline is used to determine the placebo effect.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | For a period of 8 hours from start to finish | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. |  | The bolus attempts will be observed for the 8-hour period from start to finish. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hylenex, time tagged pain pain reduction, hospice population