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

Not Applicable

Completed

• Conditions: Home Infusion Therapy; Infusion Pumps

• Registration Number: NCT00320866
• Lead Sponsor: 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.

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%).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Status Verified: 2006-05
• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Study Completion: 2007-12
• Last Update Submitted: 2008-04-29
• Last Update Posted: 2008-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
level of symptoms control

Secondary Outcome Measures

Name	Time	Method
complications and side effects

Trial Locations

Locations (1)

Ben-Gurion University of the Negev Sial Research Center for Family Medicine and Primary Care; 🇮🇱 Beer Sheva, Israel