Intramuscular Naloxone in methadone overdose

Phase 3

Recruiting

• Conditions: methadone.; Poisoning by, adverse effect of and underdosing of methadone; T40.3

• Registration Number: IRCT20120629010133N6
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 398

Inclusion Criteria

methadone overdose as the main substance
age>=18
age<=60
no background diseases
response to naloxone in initial try
opioid dependent

Exclusion Criteria

no informed consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Renarcosis. Timepoint: On-arrival blood gas analysis and then each 4 hours. Method of measurement: Blood gas.;Withdrawal syndrome. Timepoint: On-arrival band then each 4 hours. Method of measurement: Evaluation of COWS scale.;Need for naloxone. Timepoint: Each hour. Method of measurement: Blood gasometery, reduced respiratory rate, Apnea.;Need for intubation. Timepoint: hourly. Method of measurement: Clinical and laboratory indications for intubation.

Secondary Outcome Measures

Name	Time	Method
Hospitalization period. Timepoint: End of hospitalization. Method of measurement: Days of hospitalization.