Overdose, opioids, Children, Antidote, Naloxone, Intranasal. Poisoning by narcotics and psychodysleptics [hallucinogens]
Conditions
Interventions
Intervention group:.
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: Age more than 1 and less than 12 Opioid poisoning Respiratory depression Miotic pupils Unarousable as defined by Glasgow Coma Score (GCS) = 12/15
Exclusion criteria
Exclusion criteria: Still conscious on ED arrival time Patients that have received naloxone in any form in the previous 24 hours Referral cases with unknown drug intervention Patients who have been referred with IV access Presentation with apnea Nasal congestion No parental deferred consent provided GCS < 7/15 History of drug hypersensitivity relevant to naloxone Co-ingestion of other drugs Intubation before recruitment major facial trauma Epistaxis Negative urine screening test for opioids A clinical condition (such as abnormal liver function; respiratory, renal or cardiac issues) which, in the opinion of the examining medical practitioner, makes participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with return of spontaneous respiration (above minimum respiratory rate in each age group per minute). Timepoint: On arrival and within 3 minutes of naloxone administration, then each 4 hours. Method of measurement: Measuring the number of respiration in a minute. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time it takes to place IV cannula. Timepoint: From start of procedure till the end (ready for intravenous use). Method of measurement: Measured by stopwatch (per second).;Level of consciousness. Timepoint: Before intervention, 3 minute after intervention, then each 4--hour. Method of measurement: Using Glascow Coma Scale.;O2 saturation before and after naloxone administration. Timepoint: Before intervention, 3 minute after intervention, then each 4--hour. Method of measurement: Using pulse oxymeter.;Increased pCO2. Timepoint: Before intervention, 3 minute after intervention, then each 4--hour. Method of measurement: Using blood gas machine.;Need for a rescue opioid antidote in ED and afterward. Timepoint: During ED admission or afterward till discharge. Method of measurement: Record each dose naloxone, route of administration and time given during admission. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Hassanian-Moghaddam
Shahid Beheshti University of Medical Sciences
Outcome results
None listed