Home Infusion Therapy Clinical Trial
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%).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment