Examination of oxycodone for the treatment of Covid-19 patients
Design
Positive corona patients who are admitted to the intensive care unit of Masih Daneshvari Hospital with pain and shortness of breath for two months will be given oxycodone and their pain will be measured by a questionnaire.
Settings and conduct
Patients admitted to the intensive care unit of Masih Daneshvari Hospital due to covid 19 who complain of pain and shortness of breath.
Participants/Inclusion and exclusion criteria
Covid-19 positive patients
Patients hospitalized in the intensive care unit
Intervention groups
After patients with COVID are transferred to the ward, two 5 mg oxycodone tablets are given every 8 hours to start the test, and the patient's vital signs, including VAS, are recorded every 4 hours.
Main outcome variables
Patient pain rate based on questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N24
Registration date:2020-06-08, 1399/03/19
Registration timing:registered_while_recruiting
Last update:2020-06-08, 1399/03/19
Update count:0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of Oxycodone administration on pain control in patients with COVID-19
Public title
Evaluation the effects of Oxycodone administration on pain control in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Covid-19 patients
Patients hospitalized in the intensive care unit
Exclusion criteria:
Patients with dissatisfaction with drug use
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Street address
End of Niavaran, Darabadational , Research and Treatment center.
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.012
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
Pain in hospitalized patients based on the pain questionnaire
Timepoint
The first to seventh days after the onset of oxycodone
Method of measurement
Pain scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients hospitalized in the intensive care unit with covid disease who complain of pain will be treated with two oxycodone 5 mg tablets every eight hours during their hospitalization and the amount of pain and patient satisfaction will be assessed according to VAS criteria.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Dr Seyed Mohamadreza Hashemian
Street address
Down of Niavaran, Darbad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 9512
Email
iran.criticalcare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences