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Completed

NCT Number: NCT00547664

Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Good Shepherd Hospice, Lakeland, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hylenex recombinant , morphine, saline

Drug

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.

Other names: hyaluronidase human injection

Saline

Other

Subcutaneous infusion of morphine and hydromorphone (Dilaudid) with the preceded co-injection of saline.

Other names: Saline is used to determine the placebo effect.

Primary outcomes

  1. 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.

    Time frame: For a period of 8 hours from start to finish

Secondary outcomes

  1. 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.

    Time frame: For a period of 8 hours from start to finish

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

    Time frame: The bolus attempts will be observed for the 8-hour period from start to finish.

Sponsors and collaborators

Lead sponsor

HPC Healthcare, Inc.

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 22, 2007
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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