Study Results
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View full resultsBasic Information
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COMPLETED
50 participants
OBSERVATIONAL
2019-01-01
2020-02-01
Brief Summary
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Detailed Description
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After admission to the intensive care unit, all patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol administration by verbal Numeric Rating Scale (NRS). Pain score will be compared between patients with and without systemic inflammation. Systemic inflammation is defined as fulfilling at least two of the following major criteria: fever \> 38 oC or hypothermia \< 36 oC, tachycardia \> 90 beats/minute, pCO2 in arterial blood \< 4.3 kPa and leukocytes \> 12.000/mm3 or \< 4.000/mm3. Also, preoperative values of CRP \> 50 mg/L and PCT \> 0.5 ng/ml was also considered systemic inflammation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ICU admission
Exclusion Criteria
* surgery performed laparoscopically
* age younger of 18 years and older the 90 years
18 Years
90 Years
ALL
No
Sponsors
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Osijek University Hospital
OTHER
Responsible Party
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Principal Investigators
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Nenad Nešković
Role: PRINCIPAL_INVESTIGATOR
Anesthesiologyst
Locations
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University hospital centre Osijek
Osijek, , Croatia
Countries
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References
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Barakat A. Revisiting Tramadol: A Multi-Modal Agent for Pain Management. CNS Drugs. 2019 May;33(5):481-501. doi: 10.1007/s40263-019-00623-5.
He ZX, Chen XW, Zhou ZW, Zhou SF. Impact of physiological, pathological and environmental factors on the expression and activity of human cytochrome P450 2D6 and implications in precision medicine. Drug Metab Rev. 2015;47(4):470-519. doi: 10.3109/03602532.2015.1101131. Epub 2015 Nov 16.
Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30.
Mallick P, Taneja G, Moorthy B, Ghose R. Regulation of drug-metabolizing enzymes in infectious and inflammatory disease: implications for biologics-small molecule drug interactions. Expert Opin Drug Metab Toxicol. 2017 Jun;13(6):605-616. doi: 10.1080/17425255.2017.1292251. Epub 2017 Feb 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OsijekUH-6
Identifier Type: -
Identifier Source: org_study_id
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