Comparison of intranasal and intramuscular naloxone in opioid overdoses managed by ambulance staff: a double-dummy, randomised, controlled trial.
Addiction
; 117(6): 1658-1667, 2022 06.
Article
em En
| MEDLINE
| ID: mdl-35137493
ABSTRACT
AIMS:
To measure and evaluate clinical response to nasal naloxone in opioid overdoses in the pre-hospital environment.DESIGN:
Randomised, controlled, double-dummy, blinded, non-inferiority trial, and conducted at two centres.SETTING:
Participants were included by ambulance staff in Oslo and Trondheim, Norway, and treated at the place where the overdose occurred.PARTICIPANTS:
Men 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.FINDINGS:
In 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.CONCLUSION:
Intranasal 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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Overdose de Drogas
/
Overdose de Opiáceos
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Adolescent
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Addiction
Assunto da revista:
TRANSTORNOS RELACIONADOS COM SUBSTANCIAS
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Noruega