Comparison of therapeutic effects and its outcomes with morphine against methadone in combination with diazepam and haloperidol in cancer patients with severe and chronic pain referred to emergency ward.
Comparison of therapeutic effects and its outcomes with morphine against methadone in combination with diazepam and haloperidol in cancer patients with severe and chronic pain referred to emergency ward.
Design
This study is double-blind and clinical trial. This study will be patients with cancer and severe pain complaints referred to the Emergency Hospital of Amir Al-Momenin and Valiasr Hospital in Arak. A total of 92 patients are enrolled in the study.
Settings and conduct
This study is double-blind and clinical trial. This study will be patients with cancer and severe pain complaints referred to the Emergency Hospital of Amir Al-Momenin and Valiasr Hospital in Arak. A total of 92 patients are enrolled in the study.We divide patients in two groups randomly.This study is clinical trial.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients with metastatic disease of spine with pain complaints and scurvy of pain 7 and above referring to Emergency hospital of Amiralmomenin and Vali Asr arak Hospital, non-allergic to benzodiazepine and haloperidol
Exclusion criteria:Unsatisfied patients,decreased consciousness at the time of referral or during the study, blood pressure drop of SBP <90 at the time of referral or during the study,there is any contraindication in the administration of opioid or Benzodiazepine or Haloperidol, patients with scores of pain less than 7,oxygen saturation below 92%,heart rate above 90 or under 60
Intervention groups
We inject 5 milligram Metadon and 5 milligram Haloperidol in muscular and 10 milligram Diazpam intravenous slowly for 5 minute in first group.
We inject slowly 5 milligram Morphine sulphat intravenous.
Main outcome variables
Patient satisfaction-pain-drug complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N93
Registration date:2019-01-09, 1397/10/19
Registration timing:registered_while_recruiting
Last update:2019-01-09, 1397/10/19
Update count:0
Registration date
2019-01-09, 1397/10/19
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effects and its outcomes with morphine against methadone in combination with diazepam and haloperidol in cancer patients with severe and chronic pain referred to emergency ward.
Public title
Comparison of therapeutic effects and its outcomes with morphine against methadone in combination with diazepam and haloperidol in cancer patients with severe and chronic pain referred to emergency ward.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with metastatic disease of spine with pain complaints and scurvy of pain 7 and above referring to Emergency hospital of Amiralmomenin and Vali Asr arak Hospital
Non-allergic to benzodiazepine and haloperidol
Exclusion criteria:
Unsatisfied patients
Decreased consciousness at the time of referral or during the study
Blood pressure drop of SBP <90 at the time of referral or during the study
There is any contraindication in the administration of opioid or Benzodiazepine or Haloperidol
Patients with scores of pain less than 7
Oxygen saturation below 92%
Heart rate above 90 or under 60
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random number in division of groups in two groups A and B.Randomized patients are divided into two groups.Randomized allocation in clinical trial studies refers to the process of dividing participants into different groups randomly. Randomizing gives each participant equal odds for being placed in each of the groups.The candidate patients who enter the study are randomly assigned to the randomly assigned table of randomly assigned to the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
848176941
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.ARAKMU.REC.1397.084
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C80.9
ICD-10 code description
Malignant neoplasm, primary site unspecified
Primary outcomes
1
Description
Pain
Timepoint
1 and 24 hours after intervention
Method of measurement
Visual analog scale
2
Description
Patient satisfaction
Timepoint
24 hours after intervention
Method of measurement
observation
3
Description
Side effect of drugs
Timepoint
After intervention
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We inject 5 milligram Metadon and 5 milligram Haloperidol in muscular and 10 milligram Diazpam intravenous slowly for 5 minute in first group.
Category
Treatment - Drugs
2
Description
Intervention group: We inject slowly 5 milligram Morphine sulphat intravenous.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Simin Najafgholian
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
najafgholian@arakmu.ac.ir
2
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Simin Najafgholian
Street address
Amiralmomenin hospital, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
najafgholian@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Arak University Of Medical Science
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Vice Chancellor For Research, Arak University Of Medical Science
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
arjamandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Arak University Of Medical Science
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
Arak University of Medical Sciences
Full name of responsible person
Dr Ramin Parvizrad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
parvizrad@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Simin Najafgholian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street