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Despite few scientific evidence that could support the use of ketamine in adult patients undergoing acute bronchospasm requiring mechanical ventilation (MV), ketamine is largely employed in this setting. The aim of this study is therefore assess more definitively the real benefit of using ketamine in patients with severe bronchospasm, requiring ICU stay and need for MV in order to establish or refute the use of this drug as "standard therapy" in these cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h) |
|
| Fentanyl | Active Comparator | Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Active treatment |
| |
| Fentanyl |
| Measure | Description | Time Frame |
|---|---|---|
| bronchospasm improvement | Maximal airway resistance reduction in hour 3-post beginning of drug infusion | 3 hours post beginning of drug infusion |
| Measure | Description | Time Frame |
|---|---|---|
| bronchospasm improvement | Maximal airway resistance reduction in 24th hour post beginning of drug infusion | 24 hours post beginning of drug infusion |
| Time to weaning | Time (in days) to first spontaneous breathing trial post randomization up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic complacence improvement | 3 hours and 24 hours post beginning of drug infusion | |
| Air trapping improvement | intrinsic PEEP reduction in 3 and 24h post beginning of drug infusion | 3 hours and 24 hours post beginning of drug infusion |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nossa Senhora da Conceição | Porto Alegre | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25028944 | Background | Barbas CS, Isola AM, Farias AM, Cavalcanti AB, Gama AM, Duarte AC, Vianna A, Serpa Neto A, Bravim Bde A, Pinheiro Bdo V, Mazza BF, Carvalho CR, Toufen Junior C, David CM, Taniguchi C, Mazza DD, Dragosavac D, Toledo DO, Costa EL, Caser EB, Silva E, Amorim FF, Saddy F, Galas FR, Silva GS, Matos GF, Emmerich JC, Valiatti JL, Teles JM, Victorino JA, Ferreira JC, Prodomo LP, Hajjar LA, Martins LC, Malbouisson LM, Vargas MA, Reis MA, Amato MB, Holanda MA, Park M, Jacomelli M, Tavares M, Damasceno MC, Assuncao MS, Damasceno MP, Youssef NC, Teixeira PJ, Caruso P, Duarte PA, Messeder O, Eid RC, Rodrigues RG, Jesus RF, Kairalla RA, Justino S, Nemer SN, Romero SB, Amado VM. Brazilian recommendations of mechanical ventilation 2013. Part I. Rev Bras Ter Intensiva. 2014 Apr-Jun;26(2):89-121. doi: 10.5935/0103-507x.20140017. | |
| 21716106 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D001249 | Asthma |
| D001986 | Bronchial Spasm |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
| Time (in days) to first spontaneous breathing trial post randomization up to 28 days |
| Heart rate | Heart rate in 3 hours and 24h post beginning of drug infusion | 3 hours and 24 hours post beginning of drug infusion |
| Blood pressure | Blood pressure variation in 3 hours and 24hours post beginning of drug infusion | 3 hours and 24 hours post beginning of drug infusion |
| Background |
| Rowe BH, Sevcik W, Villa-Roel C. Management of severe acute asthma in the emergency department. Curr Opin Crit Care. 2011 Aug;17(4):335-41. doi: 10.1097/MCC.0b013e328348bf09. |
| 17301376 | Background | Heshmati F, Zeinali MB, Noroozinia H, Abbacivash R, Mahoori A. Use of ketamine in severe status asthmaticus in intensive care unit. Iran J Allergy Asthma Immunol. 2003 Dec;2(4):175-80. |
| 8629747 | Background | Howton JC, Rose J, Duffy S, Zoltanski T, Levitt MA. Randomized, double-blind, placebo-controlled trial of intravenous ketamine in acute asthma. Ann Emerg Med. 1996 Feb;27(2):170-5. doi: 10.1016/s0196-0644(96)70319-0. |
| 24082612 | Background | Goyal S, Agrawal A. Ketamine in status asthmaticus: A review. Indian J Crit Care Med. 2013 May;17(3):154-61. doi: 10.4103/0972-5229.117048. |
| 21730929 | Background | Miller AC, Jamin CT, Elamin EM. Continuous intravenous infusion of ketamine for maintenance sedation. Minerva Anestesiol. 2011 Aug;77(8):812-20. |
| 23208583 | Background | Abu-Hijleh M, El-Sameed Y, Eldridge K, Vadia E, Chiu H, Dreyfuss Z, Al Rabadi LS. Linear probe endobronchial ultrasound bronchoscopy with guided transbronchial needle aspiration (EBUS-TBNA) in the evaluation of mediastinal and hilar pathology: introducing the procedure to a teaching institution. Lung. 2013 Feb;191(1):109-15. doi: 10.1007/s00408-012-9439-z. Epub 2012 Dec 4. |
| 15988425 | Background | Allen JY, Macias CG. The efficacy of ketamine in pediatric emergency department patients who present with acute severe asthma. Ann Emerg Med. 2005 Jul;46(1):43-50. doi: 10.1016/j.annemergmed.2005.02.024. |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |