Comparison of Clonazepam and Lorazepam in the Treatment of Methamphetamine-Poisoned Children

Comparison of Clonazepam and Lorazepam in the Treatment of methamphetamine-Poisoned Children

single blind, parallel group randomized-controlled clinical trial with 30 cases are divided into 2 groups of oral Clonazepam or Lorazepam according to the random numbers each of them include 15 case. ________________________________________

In this double blind, randomized-controlled clinical trial, which is done to investigate the effect of oral benzodiazepin (Clonazepam or Lorazepam), in children under 12 year-old with methamphetamine poisoning who presented to pediatrics emergency department, Loghman Hakim hospital, Iran, according to the inclusion and exclusion criteria.After filling the permission form with parents according to the random numbers software, 30 patients are divided into 2 groups of fifteen. After initial administration of 0.2-mg/Kg intravenous Diazepam, oral benzodiazepines ( 0.05 mg/kg Clonazepam or Lorazepam) were only given once to prevent return of stimulant toxicity. Oral benzodiazepines were given when the patient was calm, and could be switched to oral regimen. Vital signs and clinical symptoms are recorded Upon arrival then every 6 hours.

Inclusion criteria: Children under 12-year-old age with methamphetamine poisoning exclusion criteria: Multiple-drug poisoning

After initial administration of 0.2-mg/Kg intravenous Diazepam, oral benzodiazepines ( 0.05 mg/kg Clonazepam or Lorazepam) were only given once to prevent return of stimulant toxicity. Oral benzodiazepines were given when the patient was calm, and could be switched to oral regimen.

Agitation level; duration of hospital stay; side effects of treatment (respiratory depression, deep sedation, paradoxical agitation).

First, a framework was made of numbers 1-30 , then the assignment of these numbers to group 1-2 was determined based on the random numbers table. A computer software program (www.random.org) was used to produce random numbers to allocate the medication (Clonazepam or Lorazapam) to 2 groups. Adequate medications for each group were be placed in a envelope marked with patient number and medication code.

After filling the permission form with parents, care giver divides the patients according to the random numbers and random numbers generator software into 2 groups and parents are not aware of the type of intervention. Nurse provider prescribes a medicine (0.05 mg/kg Clonazepam or Lorazepam) placed in the same drug-envelope and placed inside the envelope with the code assigned to each patient after initial administration of 0.2-mg/Kg intravenous Diazepam . Outcome assessor write the intervention and data is entered into the questionnaire based on the code of each person. Data analyser analysed final data bu SPSS software. ________________________________________

En Final data has been given to Vice-Chancellor of Research Affairs of Shahid Beheshti University of Medical Sciences

19.2.2018 -19.2.2021

Pediatrics, Clinical toxicology flow ship

All researchers are allowed to receive data details and protocols according professional ethics

Contact with authors

By email to author(faribafarnaghi@yahoo.com). It takes about 7 days.