Comparison of analgesic effect of nebulized Morphine, Fentanyl transdermal patch and oral Methadone in end stage cancer patients.
Design
In this study 90 eligible cancer patients who referred to Sayed al-shohada hospital (A teaching hospital of the Isfahan University of Medical Sciences) were selected according to study criteria and then divided in 3 groups (each group 30 patients) in random order.
Settings and conduct
The patients were followed up for three days. Severity of pain was measured in the beginning of the first day before administering the first dose and again evaluated at the end of the day. This procedure repeated for two more days at the beginning and end of each days.
For each patient a code was allocated. Analyzer and assessor were unaware about classifications of codes.
Participants/Inclusion and exclusion criteria
Criteria for entering the study including being older than 18, awareness of patient about his situation, kind of the cancer, having no allergy to Opioids, not having hypotension (systolic blood pressure lower than 110mmHg), no hypoxemia (Oxygen saturation lower than 90 percent in room temperature), no Rhinitis, no liver and kidney disorders, no Hypothyroidism or Addison's disease and no Prostatic hypertrophy.
Intervention groups
End stage cancer patients who suffering from moderate or severe pain divided in 3 groups:
for group 1 nebulized Morphine was prescribed for analgesia. for group 2 oral Methadone was prescribed for analgesia. For group 4 Fentanyl trans-dermal patch was prescribed for analgesia.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171211037834N1
Registration date:2018-02-17, 1396/11/28
Registration timing:retrospective
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Mahdi ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3771 8986
Email address
m.ebrahimi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2017-09-22, 1396/06/31
Trial completion date
empty
Scientific title
The comparison of analgesic effects of nebulized morphine with fentanyl transdermal patch and oral methadone for cancer patients in terminal stages
Public title
The analgesic effect of Nebulized Morphine, Fentanyl Transdermal Patch and Oral Methadone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from moderate or severe pain
Patient awareness about his/her situation and illness
Suitable Glasgow Coma Scale (GCS) for patient cooperation
Exclusion criteria:
Allergy to Opioids
Hypotension(Systolic Blood pressure lower than 110 mmHg)
Bradypnea (respiration rate less than 12 times per minutes)
Hypoxemia (Oxygen saturation lower than 90 percent in room temperature)
Rhinitis
Liver and kidney disorders
Hypothyroidism
Prostate hypertrophy
Addison's disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Simple personal randomization by random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
First of all for each patient a code was allocated. Codes allocations explain as follow:
101 to 130: allocated to Morphine nebulized (group 1)
201 to 230: allocated to Fentanyl trans-dermal patch (group 2)
301 to 330: allocated to oral Methadone (group 3)
A person as assessor was going to patient's bedside and asked about his/her pain severity (with Visual Analog Scale). The questioner kept unaware about the kind of medicines and the group of each patients (nebulized Morphine, Fentanyl trams-dermal patch, oral Methadone) and also about the codes classification. He was just adding the codes in the form.
Analyzer also did not know about classifications of codes and just was dividing the patient in groups according codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
ir.mui.rec.1396.3.129
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
2
Description of health condition studied
Lung cancer
ICD-10 code
C34
ICD-10 code description
Malignant neoplasm of bronchus and lung
3
Description of health condition studied
Prostate cancer
ICD-10 code
C61
ICD-10 code description
Malignant neoplasm of prostate
4
Description of health condition studied
Liver cancer
ICD-10 code
C22.0
ICD-10 code description
Liver cell carcinoma
5
Description of health condition studied
Colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
6
Description of health condition studied
Stomach cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
7
Description of health condition studied
Uterus cancer
ICD-10 code
C55
ICD-10 code description
Malignant neoplasm of uterus, part unspecified
8
Description of health condition studied
Bladder cancer
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
Pain
Timepoint
At the beginning of the study (before the intervention) and at the beginning and end of each day for 3 days.
Method of measurement
Visual Analog Score that is numbered from 0 to 10.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: nebulized group, received nebulization of 20-mg Morphine, repeated every 10minutes with a maximum of 3 nebulizations.
Category
Treatment - Drugs
2
Description
Intervention group: Fentanyl group, received 0.6 mg of transdermal Fentanyl. The transdermal patch was changed every 72 hr.
Category
Treatment - Drugs
3
Description
Control group: oral Methadone group, were treated with oral Methadone (maximum dose of 45 mg/day) divided in three doses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayed-Al-Shohada hospital
Full name of responsible person
Mahdi Ebrahimi
Street address
Farshadi Alley, Khayam St
City
Isfahan
Province
Isfehan
Postal code
0000000000
Phone
+98 31 3235 0214
Email
m.ebrahimi@resident.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Attar
Street address
No4 building, Esfahan University of Medical Sciences, Hezar Jirib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
http://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahdi Ebrahini
Position
Emergency medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No. 41, Ashrafi Isfahan Blvd.
City
Isfahan
Province
Isfehan
Postal code
0000000000
Phone
+98 31 3771 8986
Email
m.ebrahimi@resident.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahdi Ebrahimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Alzahra hodpital, Shohadaye sofe ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3771 8986
Fax
Email
m.ebrahimi@resident.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahdi Ebrahimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Alzahra hodpital, Shohadaye sofe ave
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3771 8986
Fax
Email
m.ebrahimi@resident.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All of data, after unrecognizable process are accessible.
When the data will become available and for how long
access is possible 1 year after publish.
To whom data/document is available
Access is possible just for academic research centers.
Under which criteria data/document could be used
Data Analysis is allowed and there is not any specific limitation.
From where data/document is obtainable
Requests should be send to electronic mail and attach documented mail from associated research center
What processes are involved for a request to access data/document
After request receiving, inquiry mail will be send for associated research center. After confirmation, data will be send for applicant