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The efficacy of oral naltrexone to maintain normal ventilation after acute methadone Poisoning in Opioid non-dependent Patients
Acronym :
IRCT registration number : Irct registration number : IRCT2012062910133N1
Date registered : March 22, 2013
Registration timing : Retrospective registration
   
Recruitment status : Recruitment complete
Expected recruitment start date : 2012-11-20
Expected recruitment end date : 2012-12-21
   
Scientific title : The efficacy of oral naltrexone to maintain normal ventilation after acute methadone Poisoning in Opioid non-dependent Patients
Summary :

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.

   
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
Minimum age : Year: 14         
Maximum age : Year: 100         
Gender : Both male and female
   
Health condition table is empty1 : Acute Opioids Toxicity
Condition studied : F11
Condition ICD-10 code : Mental and behavioural disorders due to use of opioids
   
Intervention/Control1 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.
Intervention category Treatment: drugs
Intervention/Control2 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.
Intervention category Treatment: drugs
   
Primary outcome measure1: Hospital Stay
Primary outcome time point Hours
Primary outcome method of measurement Based on registration of time and date on medical file
Primary outcome measure2: Acute Complications
Primary outcome time point Up to 48 hours
Primary outcome method of measurement Physical Examination, inspection and paraclinic data
Primary outcome measure3: Oxygenation (Arterial Blood Oxygen Saturation in Percent)
Primary outcome time point Continuously up to 48 hours
Primary outcome method of measurement Pulseoxymetery
Primary outcome measure4: Ventilation status
Primary outcome time point every 6 hours up to 48 hours
Primary outcome method of measurement Arterial or venous blood gas
Primary outcome measure5: Respiratory rate per minute
Primary outcome time point hour to hour up to 48 hours
Primary outcome method of measurement physical examination and inspection
   
Secondary outcome measure 1 : Level of Consciousness
Secondary outcome time point hour to hour Up to 48 hours
Secondary outcome method of measurement Physical Examination and assessment of neurologic system
Secondary outcome measure 2 : Need to naloxone
Secondary outcome time point During 48 hrs admission
Secondary outcome method of measurement Dose of Naloxone Received (mg)
Trial phase : N/A
Target sample size : 60
Randomization : randomized
Blinding : Double blind
Placebo : used
Assignment : Parallel
Other design features :
   
Centre name 1 Toxicology emergency ward and poisoning ward of Loghman-Hakim Hospital
Contact person's name Dr Hossein Hasanian-Moghaddam, Dr Abas Aghabiklooei
Country Iran, Islamic Republic Of
Contact details : Loghman-Hakim Hospital ,Kamali Ave, Makhsus St
Tehran
Tehran
13336
00982155409534
00989121481625
00982155409534
hassanian@sbmu.ac.ir
   
Ethics committee name 1 Shahid Beheshti Medical University
Date approved 2012-09-16
Reference number 122
Contact details : Velenjak, Next to Taleghani Hospital
Tehran
Tehran
Iran, Islamic Republic Of
   
Sponsor 1 Loghman-Hakim Toxicological Reserch Center dependent to Shahid-Beheshti University
Contact person's name Abdolkarim Pajoumand
Contact details : Loghman-Hakim Hospital, Kamali Ave., Mahksus Ave.
Tehran
Tehran
Iran, Islamic Republic Of
13366
009802155418175
009809122394067

dr_pajoumand@yahoo.com
   
Person responsible for general inquiries
Hosein Hassanian-Moghaddam
Affiliated Organization name Shahid Beheshti University of Medical Sciences
Position/degree Research and Educational deputy of Clinical Toxicology Department
Contact details : Poisoning Ward- Loghamn-Hakim Hospital, Kamali Ave,. Makhsus Ave.
Tehran
Tehran
Iran, Islamic Republic Of
009802155409534
009809121481628
009802155409534
hassanian@sbmu.ac.ir/hasanian2000@yahoo.comaghabikloo@yahoo.com
   
Person responsible for scientific inquiries
Abbas Aghabiklooei
Affiliated Organization name Shahid Beheshti University of Medical Sciences
Position / degree Forensic Medicine Especialist, Fellowship in Medical Toxicology
Contact details : Poisoning Ward- Loghman-Hakim Hospital, Kamali Ave., Makhsus Ave.
Tehran
Tehran
Iran, Islamic Republic Of
13336-31151
009802155409534
009809369114821
aghabikloo@yahoo.com;aghabeikloo@tums.ac.ir
   
Person responsible for updating data
Hossein Hassanian-Moghaddam
Affiliated Organization name Shahid Beheshti University of Medical Sciences
Position / degree Assistant Professor of Department of Medical Toxicology
Contact details : Loghman-Hakim Hospital, Kamali Ave., Makhsus Ave.
Tehran
Tehran
Iran, Islamic Republic Of
   
Registered by : Hossein  Hassanian-Moghaddam
Shahid Beheshti University of Medical Sciences
Velenjak, Next to Taleghani Hospital
Tehran
Tehran
Iran, Islamic Republic Of
Phone: 009802155424041
Fax: 009802155409534
hassanian@sbmu.ac.ir