Evaluation of Symptoms, Complications and Side Effects of Adding Medications Continuously To Subcutaneous Infusion (Hypodermoclysis) In Home Care Hospice Patients
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|ClinicalTrials.gov Identifier: NCT00320866|
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : April 30, 2008
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.
- To assess the level of symptoms control by the administration of morphine, metoclopramide and midazolam by hypodermoclysis versus by a syringe driver.
- 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|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||February 2002|
|Actual Study Completion Date :||December 2007|
- level of symptoms control
- complications and side effects
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 ClinicalTrials.gov identifier (NCT number): NCT00320866
|Ben-Gurion University of the Negev Sial Research Center for Family Medicine and Primary Care|
|Beer Sheva, Israel, 653|
|Principal Investigator:||Sasson Menachem, MD||Ben-Gurion University of the Negev|