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Article: Intramuscular midazolam, olanzapine, or haloperidol for the management of acute agitation: a multi-centre, double-blind, randomised clinical trial

TitleIntramuscular midazolam, olanzapine, or haloperidol for the management of acute agitation: a multi-centre, double-blind, randomised clinical trial
Authors
Issue Date2021
PublisherElsevier: Creative Commons Licenses. The Journal's web site is located at https://www.journals.elsevier.com/eclinicalmedicine
Citation
EClinicalMedicine, 2021, v. 32, p. article no. 100751 How to Cite?
AbstractBackground: The safety and effectiveness of intramuscular olanzapine or haloperidol compared to midazolam as the initial pharmacological treatment for acute agitation in emergency departments (EDs) has not been evaluated. Methods: A pragmatic, randomised, double-blind, active-controlled trial was conducted from December 2014 to September 2019, in six Hong Kong EDs. Patients (aged 18–75 years) with undifferentiated acute agitation requiring parenteral sedation were randomised to 5 mg intramuscular midazolam (n = 56), olanzapine (n = 54), or haloperidol (n = 57). Primary outcomes were time to adequate sedation and proportion of patients who achieved adequate sedation at each follow-up interval. Sedation levels were measured on a 6-level validated scale (ClinicalTrials.gov Identifier: NCT02380118). Findings: Of 206 patients randomised, 167 (mean age, 42 years; 98 [58·7%] male) were analysed. Median time to sedation for IM midazolam, olanzapine, and haloperidol was 8·5 (IQR 8·0), 11·5 (IQR 30·0), and 23·0 (IQR 21·0) min, respectively. At 60 min, similar proportions of patients were adequately sedated (98%, 87%, and 97%). There were statistically significant differences for time to sedation with midazolam compared to olanzapine (p = 0·03) and haloperidol (p = 0·002). Adverse event rates were similar across the three arms. Dystonia (n = 1) and cardiac arrest (n = 1) were reported in the haloperidol group. Interpretation: Midazolam resulted in faster sedation in patients with undifferentiated agitation in the emergency setting compared to olanzapine and haloperidol. Midazolam and olanzapine are preferred over haloperidol's slower time to sedation and potential for cardiovascular and extrapyramidal side effects. Funding: Research Grants Council, Hong Kong.
Descriptioneid_2-s2.0-85100724408
Persistent Identifierhttp://hdl.handle.net/10722/301168
ISSN
2023 Impact Factor: 9.6
2023 SCImago Journal Rankings: 3.522
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorChan, EW-
dc.contributor.authorLao, KSJ-
dc.contributor.authorLam, L-
dc.contributor.authorTsui, SH-
dc.contributor.authorLui, CT-
dc.contributor.authorWong, CP-
dc.contributor.authorGraham, CA-
dc.contributor.authorCheng, CH-
dc.contributor.authorChung, TS-
dc.contributor.authorLam, HF-
dc.contributor.authorTing, SM-
dc.contributor.authorKnott, JC-
dc.contributor.authorTaylor, DM-
dc.contributor.authorKong, DCM-
dc.contributor.authorLeung, LP-
dc.contributor.authorWong, ICK-
dc.date.accessioned2021-07-27T08:07:07Z-
dc.date.available2021-07-27T08:07:07Z-
dc.date.issued2021-
dc.identifier.citationEClinicalMedicine, 2021, v. 32, p. article no. 100751-
dc.identifier.issn2589-5370-
dc.identifier.urihttp://hdl.handle.net/10722/301168-
dc.descriptioneid_2-s2.0-85100724408-
dc.description.abstractBackground: The safety and effectiveness of intramuscular olanzapine or haloperidol compared to midazolam as the initial pharmacological treatment for acute agitation in emergency departments (EDs) has not been evaluated. Methods: A pragmatic, randomised, double-blind, active-controlled trial was conducted from December 2014 to September 2019, in six Hong Kong EDs. Patients (aged 18–75 years) with undifferentiated acute agitation requiring parenteral sedation were randomised to 5 mg intramuscular midazolam (n = 56), olanzapine (n = 54), or haloperidol (n = 57). Primary outcomes were time to adequate sedation and proportion of patients who achieved adequate sedation at each follow-up interval. Sedation levels were measured on a 6-level validated scale (ClinicalTrials.gov Identifier: NCT02380118). Findings: Of 206 patients randomised, 167 (mean age, 42 years; 98 [58·7%] male) were analysed. Median time to sedation for IM midazolam, olanzapine, and haloperidol was 8·5 (IQR 8·0), 11·5 (IQR 30·0), and 23·0 (IQR 21·0) min, respectively. At 60 min, similar proportions of patients were adequately sedated (98%, 87%, and 97%). There were statistically significant differences for time to sedation with midazolam compared to olanzapine (p = 0·03) and haloperidol (p = 0·002). Adverse event rates were similar across the three arms. Dystonia (n = 1) and cardiac arrest (n = 1) were reported in the haloperidol group. Interpretation: Midazolam resulted in faster sedation in patients with undifferentiated agitation in the emergency setting compared to olanzapine and haloperidol. Midazolam and olanzapine are preferred over haloperidol's slower time to sedation and potential for cardiovascular and extrapyramidal side effects. Funding: Research Grants Council, Hong Kong.-
dc.languageeng-
dc.publisherElsevier: Creative Commons Licenses. The Journal's web site is located at https://www.journals.elsevier.com/eclinicalmedicine-
dc.relation.ispartofEClinicalMedicine-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.titleIntramuscular midazolam, olanzapine, or haloperidol for the management of acute agitation: a multi-centre, double-blind, randomised clinical trial-
dc.typeArticle-
dc.identifier.emailChan, EW: ewchan@hku.hk-
dc.identifier.emailLao, KSJ: kiml1@connect.hku.hk-
dc.identifier.emailWong, ICK: wongick@hku.hk-
dc.identifier.authorityChan, EW=rp01587-
dc.identifier.authorityLeung, LP=rp02032-
dc.identifier.authorityWong, ICK=rp01480-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1016/j.eclinm.2021.100751-
dc.identifier.pmid33681744-
dc.identifier.pmcidPMC7910711-
dc.identifier.scopuseid_2-s2.0-85100724408-
dc.identifier.hkuros323771-
dc.identifier.volume32-
dc.identifier.spagearticle no. 100751-
dc.identifier.epagearticle no. 100751-
dc.identifier.isiWOS:000645894000034-
dc.publisher.placeUnited Kingdom-

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