NCT00320866

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (planned)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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. 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%).

Conditions

• Home Infusion Therapy
• Infusion Pumps

Interventions

Type	Name	Description
DEVICE	syringe driver

Timeline

• Start date: 2002-02-01
• Completion: 2007-12-01
• First posted: 2006-05-03
• Last updated: 2008-04-30

Locations

1 site across 1 country: Israel