The aim of this research is assessment of clininical role of oral naltrexone in prevention of respiratory depression and maintenance of normal ventilation and also prevention of loss of consciousness and its' complication like aspiration pneumonia in non-opioid dependent patients with acute pure Methadone toxicity (long-acting opioid) who comes to toxicology emergency department at loghman hospital, by prescription of 50 mg Naltraxone via gastrointestinal tract (oral). Addicted patients, active liver disease, and patient with recent history of acute coronary syndrome will be exclude from research. after intial standard emergent management non-opioid dependent patients with pure acut methadone toxicity with double blind randomization will divide to 2 groups (intervention and control group). Patients in intervention group will take single dose of 50 mg naltyrexone. Both group will admit to ward at least for 48 hours and under go respiratory monitoring by physical examination, inspection,oxygen saturation monitoring with pulseoxymetery, and ventilation by checking arterial blood gas at the ward. At the end the respiratory status and the need for Naloxone prescription and hospita stay will compaire between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012062910133N1
Registration date:2013-03-22, 1392/01/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-22, 1392/01/02
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
Toxicological reserach Center/Loghman-Hakim Hospital Poison Center
Expected recruitment start date
2012-11-20, 1391/08/30
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of oral naltrexone to maintain normal ventilation after acute methadone Poisoning in Opioid non-dependent Patients
Public title
The role of naltrexone in opioid toxicity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The acutely methadone-poisoned patients ;opioid non-dependent patients;
Exclusion criteria:
The addicted patients (Opioid-dependent patients); Active liver disease; Acute methadone poisoning with development of complications (aspiration pneumonia, brain trauma, and cardiogenic or non-cardiogenic pulmonary edema); History of acute coronory syndrome in last 3 weeks
Age
From 14 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti Medical University
Street address
Velenjak, Next to Taleghani Hospital
City
Tehran
Postal code
Approval date
2012-09-16, 1391/06/26
Ethics committee reference number
122
Health conditions studied
1
Description of health condition studied
Acute Opioids Toxicity
ICD-10 code
F11
ICD-10 code description
Mental and behavioural disorders due to use of opioids
Primary outcomes
1
Description
Oxygenation (Arterial Blood Oxygen Saturation in Percent)
Timepoint
Continuously up to 48 hours
Method of measurement
Pulseoxymetery
2
Description
Ventilation status
Timepoint
every 6 hours up to 48 hours
Method of measurement
Arterial or venous blood gas
3
Description
Hospital Stay
Timepoint
Hours
Method of measurement
Based on registration of time and date on medical file
4
Description
Acute Complications
Timepoint
Up to 48 hours
Method of measurement
Physical Examination, inspection and paraclinic data
5
Description
Respiratory rate per minute
Timepoint
hour to hour up to 48 hours
Method of measurement
physical examination and inspection
Secondary outcomes
1
Description
Level of Consciousness
Timepoint
hour to hour Up to 48 hours
Method of measurement
Physical Examination and assessment of neurologic system
2
Description
Need to naloxone
Timepoint
During 48 hrs admission
Method of measurement
Dose of Naloxone Received (mg)
Intervention groups
1
Description
Intervention group;
After emergency management (if needed) the patients in intervention group will take a single dose of 50mg naltrexone orally . During the hospital stay, the prevalence of respiratory depression or respiratory arrest, and loss of consciousness will be assess in these patients hourly by physical examination and monitoring of oxygenation and CO2 pressure of the blood (based on arterial blood gases analysis), and the O2 saturation by pulse oxymetery.
Category
Treatment - Drugs
2
Description
Control group;
The patients in control group after emergency management (if needed) will take a placebo drug. These patient during hospital admission will monitor regarding to respiratory depression or arrest and loss of consciousness by hourly physical examination, arterial Pco2 and oxygenation by arterial blood gas and pulseoxymetery respectively.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Toxicology emergency ward and poisoning ward of Loghman-Hakim Hospital
Full name of responsible person
Dr Hossein Hasanian-Moghaddam, Dr Abas Aghabiklooei
Street address
Loghman-Hakim Hospital ,Kamali Ave, Makhsus St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Loghman-Hakim Toxicological Reserch Center dependent to Shahid-Beheshti University
Full name of responsible person
Abdolkarim Pajoumand
Street address
Loghman-Hakim Hospital, Kamali Ave., Mahksus Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Loghman-Hakim Toxicological Reserch Center dependent to Shahid-Beheshti University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hosein Hassanian-Moghaddam
Position
Research and Educational deputy of Clinical Toxicology Department