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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00320866
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : April 30, 2008
Ben-Gurion University of the Negev
Information provided by:
Soroka University Medical Center

Brief Summary:

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.


  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%).

Condition or disease Intervention/treatment Phase
Home Infusion Therapy Infusion Pumps Device: syringe driver Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2002
Actual Study Completion Date : December 2007

Primary Outcome Measures :
  1. level of symptoms control

Secondary Outcome Measures :
  1. complications and side effects

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  1. Patients and caregivers that refuse to participate.
  2. Every occasion when the infusion period will be less than 48 hours.
  3. 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.
  4. Patients that will need other medications subcutaneously that are not included in the study during their study treatment period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00320866

Ben-Gurion University of the Negev Sial Research Center for Family Medicine and Primary Care
Beer Sheva, Israel, 653
Sponsors and Collaborators
Soroka University Medical Center
Ben-Gurion University of the Negev
Principal Investigator: Sasson Menachem, MD Ben-Gurion University of the Negev Identifier: NCT00320866     History of Changes
Other Study ID Numbers: SOR316302CTIL
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: April 30, 2008
Last Verified: May 2006

Keywords provided by Soroka University Medical Center:
Evaluation of Symptoms