The efficacy of intranasal naloxone in pediatric opioid overdose patients

Phase 1

Conditions: Overdose, opioids, Children, Antidote, Naloxone, Intranasal.
Poisoning by narcotics and psychodysleptics [hallucinogens]

Registration Number: IRCT20120629010133N7

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.