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IRCT20120629010133N7 IRCT 2023-06-06 Shahid Beheshti University of Medical Sciences The efficacy of intranasal naloxone in pediatric opioid overdose patients Intranasal versus intravenous administration of naloxone in pediatric opioid poisoned patients, A pilot randomized clinical trial 2021-01-16 anticipated 40 Complete https://irct.ir/trial/70140 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation sequence was generated in one session by the PI (who was not involved in treating patients) through a random digit generator website, and the PI stored the randomization list in a locked cabinet. 1-2 Overdose, opioids, Children, Antidote, Naloxone, Intranasal. Intervention group:. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hossein Hassanian-Moghaddam
Shohada-e-Tajrish hospital, Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 9201 hassanian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hossein Hassanian Moghaddam
Shohada-e-Tajrish Hospital, Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 9016 hassanian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age more than 1 and less than 12 Opioid poisoning Respiratory depression Miotic pupils Unarousable as defined by Glasgow Coma Score (GCS) ≤ 12/15 1 year 12 years Both 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. T40 Poisoning by narcotics and psychodysleptics [hallucinogens] Treatment - Drugs Intervention group: 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. 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. U1111-1260-5747 WHO Universal Trial Number DNE pharma Approved 2021-06-13 Ethics committee of Shahid Behehsti University of Medical Sciences Buiding no 2, Shahid Beheshti University of medical Sciences, Arabi St, Yaman St, Tehran Tehran Tehran Iran (Islamic Republic of)