Clinical trial NCT00547664: Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Keywords: Hylenex, time tagged pain pain reduction, hospice population
Lead sponsor: HPC Healthcare, Inc.
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2007-10-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. History of allergy or hypersensitivity to Hylenex or any components of product
2. Patients on infusion therapy for pain management up to 14 days prior to entering inpatient facilities.
3. 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.

Primary outcomes:
measure: 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.
timeFrame: For a period of 8 hours from start to finish
Secondary outcomes:
measure: 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.
timeFrame: For a period of 8 hours from start to finish
measure: The mean number of bolus attempts made over the 8-hour period between experimental and control groups.
timeFrame: The bolus attempts will be observed for the 8-hour period from start to finish.
Other outcomes:
Locations:
city: Lakeland
country: United States
facility: Good Shepherd Hospice
state: Florida
city: Tampa
country: United States
facility: LifePath Hospice, Inc.
state: Florida
city: Temple Terrace
country: United States
facility: HPC Healthcare, Inc.
state: Florida
Study officials:
affiliation: HPC Healthcare, Inc.
name: Sehwan Kim, Ph.D
role: STUDY_DIRECTOR
References: