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To compare the incidence of hospital-acquired infections between butorphanol and fentanyl.
Butorphanol can improve inflammation and promote the recovery of pro-inflammatory/anti-inflammatory cytokine balance.However, there is still a lack of relevant clinical studies on butorphanol and fentanyl for the incidence of hospital-acquired infections in ICU mechanically ventilated patients.The objective of this study was to evaluate the analgesic efficacy,safety and the incidence of nosocomial infection of butorphanol in mechanical ventilation patients between butorphanol and fentanyl.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Butorphanol tartrate | Experimental | Butorphanol tartrate on the patients with mechanical ventilation |
|
| fentanyl | Active Comparator | fentanyl on the patients with mechanical ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butorphanol Tartrate Injection | Drug | Patients of this group will receive Butorphanol Tartrate Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hospital-acquired infections | Incidence of hospital-acquired infections | one month |
| Measure | Description | Time Frame |
|---|---|---|
| duration on ventilators | patients enrolled will be followed for the duration of mechanical ventilation | one month |
| ICU stay | patients enrolled will be followed for length of ICU stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Wu | Contact | 13817976707 | wu.wei@zs-hospital.sh.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9187957 | Result | Fridkin SK, Welbel SF, Weinstein RA. Magnitude and prevention of nosocomial infections in the intensive care unit. Infect Dis Clin North Am. 1997 Jun;11(2):479-96. doi: 10.1016/s0891-5520(05)70366-4. | |
| 19952319 | Result | Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002077 | Butorphanol |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Fentanyl | Drug | Patients of this group will receive Fentanyl |
|
|
| one month |
| Hospital stay | patients enrolled will be followed for length of Hospital stay | one month |
| all cause mortality | all cause mortality | one month |
| Blood routine examination is assessed by the white blood cell count | on the 1st, 3rd，7th day after enrollment |
| Blood routine examination is assessed by neutrophil count. | on the 1st, 3rd，7th day after enrollment |
| Cytokines | Cytokines are assessed by the interleukin-1,interleukin-6 and interleukin-10 | on the 1st, 3rd，7th day after enrollment |
| adverse events | Nausea, vomiting, dry mouth, bradycardia, hypotension, respiratory depression and other adverse events | one month |
| 12626983 | Result | Meissner W, Dohrn B, Reinhart K. Enteral naloxone reduces gastric tube reflux and frequency of pneumonia in critical care patients during opioid analgesia. Crit Care Med. 2003 Mar;31(3):776-80. doi: 10.1097/01.CCM.0000053652.80849.9F. |
| 30113379 | Result | Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299. |
| 17625779 | Result | Giamberardino HI, Cesario EP, Carmes ER, Mulinari RA. Risk factors for nosocomial infection in trauma patients. Braz J Infect Dis. 2007 Apr;11(2):285-9. doi: 10.1590/s1413-86702007000200024. |
| 30989063 | Result | Baviskar AS, Khatib KI, Rajpal D, Dongare HC. Nosocomial infections in surgical intensive care unit: A retrospective single-center study. Int J Crit Illn Inj Sci. 2019 Jan-Mar;9(1):16-20. doi: 10.4103/IJCIIS.IJCIIS_57_18. |
| 17505683 | Result | Aguilar-Nascimento JE, Marra JG, Slhessarenko N, Fontes CJ. Efficacy of National Nosocomial Infection Surveillance score, acute-phase proteins, and interleukin-6 for predicting postoperative infections following major gastrointestinal surgery. Sao Paulo Med J. 2007 Jan 4;125(1):34-41. doi: 10.1590/s1516-31802007000100007. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |