Trial reportAddiction (Abingdon, England)2022
Comparison of intranasal and intramuscular naloxone in opioid overdoses managed by ambulance staff: a double-dummy, randomised, controlled trial.
Trial report in Addiction (Abingdon, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- Intranasal analgesia for acute moderate to severe pain in children - a systematic review and meta-analysis.BMC pediatrics · 2023Pooled it
- A comparison of intramuscular (Zimhi) and intranasal naloxone (Narcan) in reversal of fentanyl-induced apnea: a randomized, crossover, open-label trial.Nature communications · 2025Trial
- Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT.Health technology assessment (Winchester, England) · 2024Trial
- Comparison of intranasal and intramuscular naloxone in opioid overdoses managed by ambulance staff: a double-dummy, randomised, controlled trial.Addiction (Abingdon, England) · 2022Trial
- RECOVER Guidelines: First Aid in Dogs and Cats. Evidence and Knowledge Gap Analysis With Treatment Recommendations.Journal of veterinary emergency and critical care (San Antonio, Tex. : 2001) · 2026Article
- Article
- Modeling Supports Combinatorial Effects Between Pharmacological and Non-Pharmacological Interventions to Prevent Opioid-Induced Cardiac Arrest.Clinical pharmacology and therapeutics · 2026Article
- Intranasal Naloxone Reversal of Opioid-induced Respiratory Depression in Opioid-naive Individuals and Self-reported Daily Opioid Users.Anesthesiology · 2026Article
- From fairytale to clinical practice: A response to commentaries.Addiction (Abingdon, England) · 2025Article
- Naloxone dosing in the era of synthetic opioids: Applying the Goldilocks principle.Addiction (Abingdon, England) · 2025Review
- High-dose naloxone formulations are not as essential as we thought.Harm reduction journal · 2024Review
- Acute opioid overdose in pediatric patients.Journal of the American College of Emergency Physicians open · 2024Article
- Clinical Pharmacokinetics and Pharmacodynamics of Naloxone.Clinical pharmacokinetics · 2024Review
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo measure and evaluate clinical response to nasal naloxone in opioid overdoses in the pre-hospital environment.
designRandomised, controlled, double-dummy, blinded, non-inferiority trial, and conducted at two centres.
settingParticipants were included by ambulance staff in Oslo and Trondheim, Norway, and treated at the place where the overdose occurred.
participantsMen and women age above 18 years with miosis, rate of respiration ≤8/min, and Glasgow Coma Score <12/15 were included. Informed consent was obtained through a deferred-consent procedure. INTERVENTION AND COMPARATOR: A commercially available 1.4 mg/0.1 mL intranasal naloxone was compared with 0.8 mg/2 mL naloxone administered intramuscularly. MEASUREMENTS: The primary end-point was restoration of spontaneous respiration of ≥10 breaths/min within 10 minutes. Secondary outcomes included time to restoration of spontaneous respiration, recurrence of overdose within 12 hours and adverse events.
findingsIn total, 201 participants were analysed in the per-protocol population. Heroin was suspected in 196 cases. With 82% of the participants being men, 105 (97.2%) in the intramuscular group and 74 (79.6%) in the intranasal group returned to adequate spontaneous respiration within 10 minutes after one dose. The estimated risk difference was 17.5% (95% CI, 8.9%-26.1%) in favour of the intramuscular group. The risk of receiving additional naloxone was 19.4% (95% CI, 9.0%-29.7%) higher in the intranasal group. Adverse reactions were evenly distributed, except for drug withdrawal reactions, where the estimated risk difference was 6.8% (95% CI, 0.2%-13%) in favour of the intranasal group in a post hoc analysis.
conclusionIntranasal naloxone (1.4 mg/0.1 mL) was less efficient than 0.8 mg intramuscular naloxone for return to spontaneous breathing within 10 minutes in overdose patients in the pre-hospital environment when compared head-to-head. Intranasal naloxone at 1.4 mg/0.1 mL restored breathing in 80% of participants after one dose and had few mild adverse reactions.
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