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OpenTrials
Completed

NCT Number: NCT00320866

Evaluation of Symptoms, Complications and Side Effects of Adding Medications Continuously To Subcutaneous Infusion (Hypodermoclysis) In Home Care Hospice Patients

Background: Terminal patients are often unable to swallow and need medications to control symptoms. In these cases medications are administered continuously and subcutaneously by a syringe driver. A syringe driver is an expensive and sophisticated equipment to operate. Hypodermoclysis is a useful and easy alternative used in the homecare setting for hydration.

Objectives:

1. To assess the level of symptoms control by the administration of morphine, metoclopramide and midazolam by hypodermoclysis versus by a syringe driver. 2. To assess the complications and side effects of infusing these medications continuously by hypodermoclysis versus by a syringe driver.

Methods: Patients in the homecare setting who meet the criteria for parentral infusion and suffer: pain, vomit/nausea and/or agitation will be recruited for the study.

A double blind crossover methodology will be used. Each patient will serve as both intervention and control, and both patient and medical staff will be blinded to the medication route administration. A research nurse will administer the medications. Crossover will take place 48 hours thereafter. A research assistant will conduct evaluation of symptoms and side effects for a period of 4 days. A sample size of 27 patients will be included in the study (calculated for a significance level of 95% and power of 80%).

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Key information

Conditions

Home Infusion Therapy Infusion Pumps

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ben-Gurion University of the Negev Sial Research Center for Family Medicine and Primary Care

Beersheba, 653, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients in the home care unit that need medication/s continuously subcutaneously with symptoms level of 6 or higher on a visual analogue scale (VAS) for that symptom.

Exclusion criteria

  • Patients and caregivers that refuse to participate.
  • Every occasion when the infusion period will be less than 48 hours.
  • Every occasion when the patient and/or main care giver are not able to provide reliable information by the judgment of the medical staff person or research worker.
  • Patients that will need other medications subcutaneously that are not included in the study during their study treatment period.

Treatment and study plan

syringe driver

Device

Primary outcomes

  1. level of symptoms control

Secondary outcomes

  1. complications and side effects

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Collaborators

  • Ben-Gurion University of the Negev

Registry information

Important dates

Study start
2002
Study completion
2007
First posted
May 3, 2006
Registry last updated
Apr 30, 2008

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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