Determining the effect of N-acetylcysteine combined with the therapeutic effect of Naloxone in improving methadone poisoning
Design
Clinical trial with control and intervention groups, with parallel group, not blind, non-random assignment to intervention and control group, phase 3 on 64 patients
Settings and conduct
Clinical and therapeutic studies are performed on methadone poisoned patients who went to Ayatollah Kashani hospital in Shahrekord ,so that after obtaining their written consent , they were included in the study and divided into two groups of control and intervention non-randomly(Even days in the control group and odd days in the intervention group).
The control group is treated with naloxone the intervention group is treated with Naloxone and N_acetylcysteine.
Blood samples are taken from the patients, 5 days befor and after interventing,and the variables are measured and finally all are compared in the two groups of control and intervention to determine the effect of N_acetylcysteine.
Participants and the main researcher, health care personnel, those who evaluate the outcome are aware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
Admission conditions:All patients who have a triad of opioid poisoning, including:loss of consciousness,hypoxia and Myotic pupil and have a positive methadone level in urinalysis
Exclusion criteria:patient dissatisfaction and Subjects who use supplements and drugs with similar effects or interfering with Naloxone and N-acetylcysteine
Intervention groups
The control group is treated with Naloxone and the intervention group is treated with Naloxone and N_acetylcysteine
The Evaluation of the Effect of N-acetylcysteine Combined With Therapeutic Effect of Naloxone in Improving Methadone Poisoning
Public title
The Evaluation of the Effect of N-acetylcysteine in Improving Methadone Poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have a triad of opioid poisoning, including: loss of consciousness, hypoxia and Myotic pupil
Have a positive methadone level in urinalysis (UA)
Exclusion criteria:
Patient dissatisfaction
Subjects who use supplements and drugs with similar effects or interfering with Naloxone and N-acetylcysteine
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics committee of Shahrekord university of medical sciences
Street address
Parastar Ave ;Ayatollah Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814835465
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.SKUMS.REC.1399.244
Health conditions studied
1
Description of health condition studied
Poisoning by Methadone
ICD-10 code
T40.3X4
ICD-10 code description
Poisoning by Methadone, undetermined
Primary outcomes
1
Description
Serum levels of Aspartate aminotransferase enzyme
Timepoint
Measurement of the variable before intervening and 5 days after beginning the treatment with N-acetylcysteine
Method of measurement
Measured by Pars Azmoun commercial kitson on blood serum with an autoanalyzer system (BT3000, Italy)
2
Description
Serum levels of Alanine transaminase
Timepoint
Measurement of the variable before intervening and 5 days after beginning the treatment with N-acetylcysteine
Method of measurement
By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer system (BT3000, Italy)
3
Description
Serum levels of Blood urea Nitrogen
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Measured by Pars Azmoun commercial kits on blood serum with an autoanalyzer system(BT3000, Italy)
4
Description
Serum levels of Creatinine
Timepoint
Measurement of the variable before tntervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Measured by Pars Azmoun commercial kits on blood serum with an autoanalyzer system (BT3000, Italy)
5
Description
Serum levels of Uric acid
Timepoint
Measurement of the variable before the intervening and 5 days after beginning treatment with N-acetylcysteine
Method of measurement
By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer system(BT3000, Italy)
6
Description
Serum levels of Malondialdehyde
Timepoint
Measurement of the variable before the intervention and 5 days after the beginning treatment with N-acetylcysteine
Method of measurement
To 50 μl of serum, 50 μl of 0.05% solution of BHT (Butylated hydroxytoluene) in 0.95% ethanol, 400 μl of 0.44 mM phosphoric acid and 100 μl of 42 mM thiobarbituric acid solution (TBA) is added for 1 hour. The temperature is incubated at 100 ° C and then the samples are placed on ice for 5 minutes and then the absorptions are read with a spectrophotometer.
7
Description
Serum levels of Lactate dehydrogenase
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer (BT3000, Italy)
8
Description
Serum levels of ferric reducing ability of plasma(FRAP)
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
In the FRAP method, triazine reagent is added to the serum sample and the resulting mixture is incubated for 10 minutes at 37 ° C. Then the absorbance of the solution is measured at a wavelength of 593 nm by a spectrophotometer.
9
Description
Blood pressure
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Mercury sphygmomanometer
10
Description
Heart rate
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Pulse oximeter
11
Description
respiratory rate
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Count the number of breaths by observing the movements of the chest
12
Description
Body Temperature
Timepoint
Measurement of the variable before the intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Mercury Therommeter
13
Description
Serum levels of Creatine phosphokinase
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer (BT3000, Italy)
14
Description
Serum levels of sodium
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer (BT3000, Italy)
15
Description
Serum levels of potassium
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
By Pars Azmoun commercial kits Measured on blood serum with an autoanalyzer (BT3000, Italy)
16
Description
Venous blood pH
Timepoint
Measurement of the variable before the intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Blood gas analyzer
17
Description
Venous blood levels of Partial oxygen pressure (PO2)
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Blood gas analyzer
18
Description
Venous blood levels of Partial pressure of carbon dioxide (PCO2)
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Blood gas analyzer
19
Description
Venous blood levels of Bicarbonate ion (̄ HCO3)
Timepoint
Measurement of the variable before intervening and 5 days after beginning of treatment with N-acetylcysteine
Method of measurement
Blood gas analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In this group, treatment performed by using Naloxone and N-acetylcysteine . N-acetylcysteine is applied in therapeutic doses which used in acetaminophen poisoning, with the initial injection dose of N-acetylcysteine being infused at 150 mg / kg in 200 cc of 5% dextrose within 1 hour, followed by 50 mg / kg immediately is infused in 500 cc of 5% dextrose for 4 hours and immediately after that 100 mg / Kg in one liter of 5% dextrose is infused for 16 hours. Therapeutic intervention with 0.4 mg injectable dose of naloxone in non-addicts and 0.05 mg in addicts is administered every 5 minutes until the patient's concentration reaches above 93% and then the maintenance dose with 2.3 doses of wake up (dose that the patient with It wakes up or the patient's respiratory depression resolves) starts per hour for the patient and lasts up to 24 hours, and then we start taper naloxone so that every 6 hours we halve the dose of naloxone received by the patient to zero and eventually 5 days after beginning of treatment, blood samples are taken from patients again.Finally, all variables are compared separately in two groups of case and control to determine the effect of N-acetylcysteine.
Category
Treatment - Drugs
2
Description
Control group:In the control group, treatment performed just by Naloxone . Intervention therapy with 0.4 mg injectable dose of naloxone in non-addicts and 0.05 mg in addicts is administered every 5 minutes until the patient's concentration reaches above 93% and then the maintenance dose It starts with 2/3 dose of wake up (the dose that the patient wakes up with or the patient's respiratory depression goes away) per hour for the patient and continues for 24 hours and then we start taper naloxone so that every 6 hours the dose We halve the naloxone intake of the patient to zero and finally, after 5 days from the start of treatment,Blood samples are taken from the patient again. Finally, all variables are compared separately in case and control groups to determine the effect of N-acetylcysteine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital in Shahrekord
Full name of responsible person
Pante A Ramezannezhad
Street address
Parastar Ave ;Ayatollah Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
5891588167
Phone
+98 38 3226 4841
Email
drzahrakarimi@gmail.com
Web page address
http://kashanihp.skums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Kashani Ave; Shahrekord university of medical sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 2907
Email
drzahrakarimi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Pante A Ramezannezhad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Forensic Medicine
Street address
Parastar Ave ;Ayatollah Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
0098 38 32264825-41
Fax
+98 38 3222 8600
Email
ramezannezhad.p@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Pante A ramezannezhad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Forensic Medicine
Street address
Kashani hospital;Parastar avenue
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
0098 38 32264825-41
Email
ramezannezhad.p@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Pante A Ramezannezhad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Forensic Medicine
Street address
Parastar Ave ;Ayatollah Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
0098 38 32264825-41
Email
ramezannezhad.p@skums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available