Home Infusion Therapy Clinical Trial
| Verified date | May 2006 |
| Source | Soroka University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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%).
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | December 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Ben-Gurion University of the Negev Sial Research Center for Family Medicine and Primary Care | Beer Sheva |
| Lead Sponsor | Collaborator |
|---|---|
| Soroka University Medical Center | Ben-Gurion University of the Negev |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | level of symptoms control | |||
| Secondary | complications and side effects |