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Comparison of entonox and oxygen in effect of the pain of detoxification period in drug users

Protocol summary

Study aim
Determining the effect of Antonex on reducing the pain of substance-dependent patients compared to oxygen therapy
Design
A clinical trial with the control group, with parallel groups, randomized phase 3 in 60 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The study will be conducted at Hazrat Rasool Akram Hospital in Tehran. A person who consumes drugs according to his habit of consumption two times in the morning and the evening, the pain of his drug withdrawal symptoms starts at these times. Therefore, the person undergoing treatment will be exposed to Entonex according to the prescribed dose. The intensity of patients' physical pain will be measured according to VAS criteria. This pain scale represents a 10-cm line printed on a piece of paper with markers at each end, with “no pain” at one end and “worst pain” or “indescribable pain” at the other end. The person puts a cross X on the line to indicate the intensity of their pain.
Participants/Inclusion and exclusion criteria
Patients with a history of drug abuse, such as opium, opium sap, burnt sap, heroin and its derivatives, methadone, morphine, buprenorphine
Intervention groups
The first group will be treated with inhalation intoxication medicine (in the form of 80% oxygen + 20% nitrous oxide) for 10 days through the connecting tube. Every day, the first 15 minutes of Entonex with the prescribed dose to relieve pain and 30 minutes of oxygen to clean the lungs, remove withdrawal symptoms, and re-inhale Entonex for 5 minutes and then 10 minutes of oxygen, for a total of 60 minutes. It will take a long time. For the second group, oxygen therapy will be prescribed daily for 60 minutes.
Main outcome variables
Severity of pain experienced as a result of drug withdrawal syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180313039085N4
Registration date: 2024-05-13, 1403/02/24
Registration timing: prospective

Last update: 2024-05-13, 1403/02/24
Update count: 0
Registration date
2024-05-13, 1403/02/24
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6683 0007
Email address
tramim@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of entonox and oxygen in effect of the pain of detoxification period in drug users
Public title
Comparison of entonox and oxygen in effect of the pain of detoxification period in drug users
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of drug abuse who have filed a medical case with the intention of quitting drugs
Exclusion criteria:
Suffering from underlying diseases such as diabetes, cardiovascular, respiratory and high blood pressure Use of narcotics and sedatives Failure to refer for drug intoxication En Patients' unwillingness to participate in the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was non-probabilistic and easy. Then, patients were randomly divided into four groups. In this randomization method, quadruple therapy blocks (with 10 probabilities) were randomly moved back and forth, and a balanced random list of two treatment groups was obtained to ensure that if the total number of samples were not complete, both groups would be equal.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
thics committee of Iran University of Medical Sciences
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.IUMS.REC.1402.935

Health conditions studied

1

Description of health condition studied
withdrawal syndrome
ICD-10 code
F11.3
ICD-10 code description
Withdrawal state

Primary outcomes

1

Description
Pain
Timepoint
Daily
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will be treated with inhaled nitrous oxide (a combination of 80% oxygen + 20% nitrous oxide) for ten days through the connecting tube. Every day, first, nitrous oxide for 15 minutes to relieve pain and oxygen for 30 minutes to clean the lungs and eliminate the withdrawal symptoms will be considered. Then, re-inhalation of nitrous oxide for 5 minutes and then oxygen for 10 minutes will be considered, for a total of 60 minutes.
Category
Treatment - Drugs

2

Description
Control group: Oxygen therapy will be prescribed daily for 60 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrate Rasoole Akram Hospital
Full name of responsible person
Tayeb Ramim
Street address
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 0000
Email
tayebramim@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
tayebramim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Tayeb Ramim
Position
Deputy of Educational and Research
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
Rasool Akram Hospital, Mazyar Mansori Ave, Satar Khan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6683 0007
Fax
Email
tayebramim@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tayeb Ramim
Position
Deputy of Educational and Research
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
Rasool Akram Hospital, Mazyar Mansori Ave, Satar Khan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6683 0007
Fax
Email
tayebramim@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Tayeb Ramim
Position
Deputy of Educational and Research
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
Rasool Akram Hospital, Mazyar Mansori Ave, Satar Khan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6683 0007
Fax
Email
tayebramim@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not 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
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