Evaluation of Symptoms, Complications and Side Effects of Adding Medications Continuously To Subcutaneous Infusion (Hypodermoclysis) In Home Care Hospice Patients
|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|
|Home Infusion Therapy Infusion Pumps||Device: syringe driver|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||February 2002|
|Study Completion Date :||December 2007|
- level of symptoms control
- complications and side effects
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|