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The effect of nebulized naloxone in comparison with intravenous naloxone in patients with methadone overdose, a randomized clinical trial study

Protocol summary

Study aim
The effect, complications, benefits, and feasibility of administration of nebulized naloxone The effect, complications, benefits, and feasibility of administration of naloxone infusion Comparison of effects, complications, benefits, and feasibility of administration of naloxone infusion versus nebulized naloxone
Design
A Phase II randomized clinical trial on 60 patients in which randomization was done using the envelopes containing the name of intervention or control groups.
Settings and conduct
All opioid-dependent cases who get poisoned with methadone and responded to the administration of naloxone in the emergency department.
Participants/Inclusion and exclusion criteria
Inclusion criteria include those methadone overdosed cases >18 and <60 years old who are otherwise safe with no background diseases using methadone as the primary drug and signs of opioid overdose. All patients should be dependent on opioids.
Intervention groups
using nebulized naloxone (vs. traditional naloxone infusion) in opioid-dependent patients referred with methadone overdose
Main outcome variables
Intubation; O2 saturation; consciousness level (GCS score); withdrawal syndrome (Cows scale); taking additional doses (rescue dose) of naloxone

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120629010133N4
Registration date: 2022-07-07, 1401/04/16
Registration timing: prospective

Last update: 2022-07-07, 1401/04/16
Update count: 0
Registration date
2022-07-07, 1401/04/16
Registrant information
Name
Hossein Hassanian-Moghaddam
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4041
Email address
hassanian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-16, 1401/04/25
Expected recruitment end date
2023-07-16, 1402/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nebulized naloxone in comparison with intravenous naloxone in patients with methadone overdose, a randomized clinical trial study
Public title
Nebulized naloxone in methadone poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Methadone Overdose >18 and <60 Response to naloxone Opioid dependency Spontaneous respiration
Exclusion criteria:
No consent to participate nasal congestion Current catching cold Apnea Intubation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the project we will write the name "Naloxone infusion" and Nebulized naloxone" on 30 papers each. All papers will be folded and inserted into an envelope and all envelopes will be put in a small box and the head nurse will take it. For randomization after recruitment and assessment of eligibility for inclusion & exclusion criteria and no contraindication for initiation of each treatment, the head nurse will be asked to open the envelopes at random and present them to the physician in charge
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
Ethic Commitee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2022-06-26, 1401/04/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.162

Health conditions studied

1

Description of health condition studied
Opioid, Methadone, Poisoning, naloxone infusion, Nebulized naloxone
ICD-10 code
T40.3
ICD-10 code description
Poisoning by, adverse effect of and underdosing of methadone

Primary outcomes

1

Description
O2 Saturation
Timepoint
On admission, then each hour till 6 hours, then each 3 hours
Method of measurement
Pulse oxymetery

2

Description
pCo2
Timepoint
On admission, then each hour till 6 hours, then each 3 hours
Method of measurement
Blood gasometery

3

Description
Level of consiousness using Glasgow Coma Scale
Timepoint
On admission, then each hour till 6 hours, then each 3 hours
Method of measurement
Physical Examination

Secondary outcomes

1

Description
Withdrawal Syndrome using COWS scale
Timepoint
Each 3 hours
Method of measurement
Examination

Intervention groups

1

Description
Intervention group: naloxone administration by jet nebulizer, using 2/3 of i.v. naloxone in emergency department to avoid re-narcosis
Category
Treatment - Drugs

2

Description
Control group: naloxone administration by pump infusion or serum set, using 2/3 of i.v. naloxone in emergency department to avoid re-narcosis
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Hossein Hassanian-Moghaddam
Street address
Kamali Avenue, South Karegar
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5540 9534
Email
hassanian@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Vice chancelor of research, Arabi St, Velenjak, Yaman street
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Fax
+98 21 2243 9780
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Edalatkhah
Position
Emergency medicine Specialist andregistrar for clinical toxicology
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Loghman Hakim Hospital, Kamali Ave, South Karegar
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5540 9534
Email
abbas_edalatkhah@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein hassanian-Moghaddam
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Toxicology
Street address
Loghman Hakim Hospital, Kamali Ave, South Karegar
City
Tehran
Province
Tehran
Postal code
دانشیار
Phone
+98 21 5540 9534
Email
hassanian@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Edalatkhah
Position
Emergency medicine Specialist and registrar in Clinical Toxicology
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Loghman Hakim Hospital, Kamali Ave, South Karegar
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5540 9534
Email
abbas_edalatkhah@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
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
We will share the data after decoding if there was a reasonable request
When the data will become available and for how long
6 month after publication, if SBMU accept sharing
To whom data/document is available
Only academics
Under which criteria data/document could be used
Not decided yet
From where data/document is obtainable
The corresponding author of the published article
What processes are involved for a request to access data/document
The type of requested data should be defined and we will try to respond to the queries within one month
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