title: Randomized controlled trial comparing the effectiveness and safety of intranasal and intramuscular naloxone for the treatment of suspected heroin overdose.
abstract: OBJECTIVE
  Traditionally, the opiate antagonist naloxone has been administered parenterally; however, intranasal (i.n.) administration has the potential to reduce the risk of needlestick injury. This is important when working with populations known to have a high prevalence of blood-borne viruses. Preliminary research suggests that i.n. administration might be effective, but suboptimal naloxone solutions were used. This study compared the effectiveness of concentrated (2 mg/ml) i.n. naloxone to intramuscular (i.m.) naloxone for suspected opiate overdose.
  
  
  METHODS
  This randomized controlled trial included patients treated for suspected opiate overdose in the pre-hospital setting. Patients received 2 mg of either i.n. or i.m. naloxone. The primary outcome was the proportion of patients who responded within 10 minutes of naloxone treatment. Secondary outcomes included time to adequate response and requirement for supplementary naloxone. Data were analysed using multivariate statistical techniques.
  
  
  RESULTS
  A total of 172 patients were enrolled into the study. Median age was 29 years and 74% were male. Rates of response within 10 minutes were similar: i.n. naloxone (60/83, 72.3%) compared with i.m. naloxone (69/89, 77.5%) [difference: -5.2%, 95% confidence interval (CI) -18.2 to 7.7]. No difference was observed in mean response time (i.n.: 8.0, i.m.: 7.9 minutes; difference 0.1, 95% CI -1.3 to 1.5). Supplementary naloxone was administered to fewer patients who received i.m. naloxone (i.n.: 18.1%; i.m.: 4.5%) (difference: 13.6%, 95% CI 4.2-22.9).
  
  
  CONCLUSIONS
  Concentrated intranasal naloxone reversed heroin overdose successfully in 82% of patients. Time to adequate response was the same for both routes, suggesting that the i.n. route of administration is of similar effectiveness to the i.m. route as a first-line treatment for heroin overdose.
authors.affiliation: Victoria University, School of Nursing and Midwifery, St Albans, Victoria, Australia. deb.kerr@vu.edu.au
authors.forename: Debra
authors.initials: D
authors.lastname: Kerr
authors.forename: Anne-Maree
authors.initials: AM
authors.lastname: Kelly
authors.forename: Paul
authors.initials: P
authors.lastname: Dietze
authors.forename: Damien
authors.initials: D
authors.lastname: Jolley
authors.forename: Bill
authors.initials: B
authors.lastname: Barger
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000488:Allied Health Personnel; D000701:Analgesics, Opioid / Q000506:poisoning*; D062787:Drug Overdose / Q000188:drug therapy; D004632:Emergency Medical Services; D005260:Female; D003932:Heroin / Q000506:poisoning*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage* / Q000009:adverse effects; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D014739:Victoria; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D009292:Narcotic Antagonists; D009270:Naloxone; D003932:Heroin