Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320866
Status:
COMPLETED
Last Update Posted:
2008-04-30
First Post:
2006-05-01
Brief Title:
Evaluation of Symptoms Complications and Side Effects of Adding Medications Continuously To Subcutaneous Infusion Hypodermoclysis In Home Care Hospice Patients
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 vomitnausea andor 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
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 vomitnausea andor 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None