Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

Condition(s) targeted: Pain Management

Intervention: Hylenex recombinant , morphine, saline (Drug); Saline (Other)

Phase: N/A

Status: Recruiting

Sponsored by: HPC Healthcare, Inc.

Official(s) and/or principal investigator(s):
Sehwan Kim, Ph.D, Study Director, Affiliation: HPC Healthcare, Inc.

Overall contact:
Sehwan Kim, Ph.D, Phone: (813) 877-2200, Email: kims@hpchealthcare.org

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.

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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.

The mean number of bolus attempts made over the 8-hour period between experimental and control groups.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Sehwan Kim, Ph.D, Phone: (813) 877-2200, Email: kims@hpchealthcare.org

Good Shepherd Hospice, Lakeland, Florida 33815, United States; Recruiting
Teresa Kirkland, BS, RN, Phone: 813-877-2200, Email: kirklandt@hpchealthcare.org

LifePath Hospice, Inc., Tampa, Florida 33609, United States; Recruiting
Teresa Kirkland, BS, RN, Phone: 813-877-2200, Email: kirklandt@hpchealthcare.org

HPC Healthcare, Inc., Temple Terrace, Florida 33637, United States; Recruiting
Sehwan Kim, Ph.D, Phone: 813-357-5667, Email: kims@hpchealthcare.org
Michelle Salvat, M.D., Principal Investigator

Starting date: January 2008
Last updated: January 28, 2009