Postoperative Pain Clinical Trial
Official title:
Comparison Between Ketamine and Tramadol for Pain Management After Major Upper Abdominal Surgery
Verified date | June 2015 |
Source | Attikon Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Interventional |
The purpose of the study is the comparison between ketamine and tramadol, regarding the analgesia quality and efficiency, in patients receiving Patient Controlled Analgesia (PCA) morphine, after major upper abdominal surgeries such as hepatectomies, gastrectomies, Whipple procedures and peripheral pancreatectomies. The goal is to bring out an improved analgesia scheme, which can be applied to the clinical work and refine the analgesia provided for major procedures which require increased postoperative opioids doses. In the study, half of patients will receive continuous intravenous infusion of tramadol and Patient Controlled Analgesia morphine and the other half will receive continuous intravenous infusion of ketamine and Patient Controlled Analgesia morphine postoperatively after major upper abdominal surgery. The successful combination of different drugs targets at the improvement of the analgesia provided, the reduction of complications and the exploitation of the pharmacodynamic properties of each drug.
Status | Completed |
Enrollment | 42 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Age between 18 and 70 years - American Society of Anesthesiologists (ASA) physical status I and II - Major Upper abdominal Surgery (Elective Hepatectomy, Gastrectomy, Whipple procedure, Peripheral Pancreatectomy) Exclusion Criteria: - Patient's refusal to participate in the study - Performance of regional anaesthesia - Unsuitability for Patient Controlled Analgesia - Current opiates use - Drug addiction - Chronic Pain Syndromes - Alcohol addiction - Epilepsy - Psychiatric disorders - Use of Monoamine Oxidase Inhibitor or Selective Serotonin Reuptake Inhibitor - Sleep Apnea Syndrome - Extrapyramidal Syndromes - Severe liver, kidney or heart disease - Known allergy to ketamine, tramadol or morphine. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | 2nd Department of Anesthesiology, Attikon University Hospital | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
Attikon Hospital |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of morphine consumption expressed as milligrams postoperatively in abdominal surgery. | 48 hours postoperatively | No |
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