Comparison effect of tow methods of naloxone administration on improvement of clinical manifestation in patients with opium toxicity.
Design
Clinical controlled trial with parallel design will perform on 60 patients with known opium toxicity referred to hospital emergency. Patients with spontaneous breathing more than 6 breaths per minute, without unstable hemodynamic and nose bleeding will be assigned in two groups with randomized block design. In intervention group naloxone is administrated using a nebulizer and in control group naloxone is administrated intravenously. Changes in vital sings, consciousness and saturation of oxygen are evaluated in two groups.
Settings and conduct
This study is performed in the emergency department of Loghman Hospital in Tehran. This study was performed under the supervision of an emergency medicine. Patients and individuals who measure clinical changes are unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Known opium toxicity; age more than 15 years; spontaneous breathing more than 6 breathes per minute. Exclusion criteria: Naloxone allergy, Nose bleeding; unstable hemodynamic.
Intervention groups
Intervention group: Administration of naloxone using nebulizer oxygen mask at dose of 2 mg diluted in 3 ml normal saline. Control group: Administration of intravenous naloxone at dose of 0.04 mg diluted in 5 ml normal saline.
Comparison effects of two methods of naloxone administration on improvement of clinical manifestations in patients with opium toxicity.
Public title
Comparison of two methods of naloxone administration on improvement of clinical manifestations in patients with opium poisoning.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Known opium toxicity
Spontaneous breathing more than 6 breath per minute
Age above 15 years old
Exclusion criteria:
Nose bleeding
Unstable hemodynamic
Allergy to naloxone
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using stratified permuted block randomization. Patients are divided into two strata of male and female. For each stratum, a separate random assignment continues to reach the sample size. For random assignment in each stratum, four blocks of (A, B), which include different states of test and control sequences (AABB, ABAB …), are used. Block selection and randomization is done with website (URL: https://www.sealedenvelope.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
Because all patients receive oxygen with mask, patients and individuals evaluating response to treatment are unaware of the type of intervention received. But emergency physician, nurses, and researchers are aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University Of Medical Sciences
Street address
Semnan university of medical sciences, Shahid Akhlaghi intersection, Basij Blvd.,Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.SEMUMS.REC.1399.185
Health conditions studied
1
Description of health condition studied
Opioid dependence
ICD-10 code
F11.22
ICD-10 code description
Opioid dependence with intoxication
Primary outcomes
1
Description
Level of consciousness
Timepoint
5 min, 10 min, 15 min and 20 min after naloxone administration
Method of measurement
Glasgow Coma Scale
2
Description
Vital signs
Timepoint
5 min, 10 min and 20 min after naloxone administration
Method of measurement
Ward monitor
3
Description
Clinical opiate withdrawal signs
Timepoint
5 min, 10 min and 20 min after naloxone administration
Method of measurement
Clinical Opiate Withdrawal Scale (COWS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administration of naloxone hydrochloride (Tolidaru Pharmaceutical Co, Tehran, Iran) at dose of 2 mg with nebulizer mask that diluted in 3 ml normal saline.
Category
Treatment - Drugs
2
Description
Control group: Naloxone hydrochloride (Tolidaru Pharmaceutical Co, Tehran, Iran) administration intravenously at dose of 0.04 mg diluted in 4 ml normal saline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman hospital
Full name of responsible person
Fatemeh Keshavarz
Street address
Loghman hospital, south kargar street, Tehran, Iran.
City
Semnan
Province
Semnan
Postal code
21 5541 9005
Phone
+98 21 5541 9005
Email
Soli257@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan university of medical sciences, Shahid Akhlaghi intersection, Basij Blvd.,Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3365 4190
Email
Soli257@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
1
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
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing faculty, Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
0098 23 3354190
Email
Soli257@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasim Zamani
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Department of emergency, Loghman hospital, south of kargar street, Tehran.
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5541 9005
Email
Soli257@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing faculty, Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
0098 23 3354190
Email
Soli27@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD