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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 3 August 2015
Main ID:  NCT02499341
Date of registration: 12/07/2015
Prospective Registration: No
Primary sponsor: Attikon Hospital
Public title: A Comparison Study Between Ketamine Versus Tramadol for Pain Management After Major Upper Abdominal Surgery
Scientific title: Comparison Between Ketamine and Tramadol for Pain Management After Major Upper Abdominal Surgery
Date of first enrolment: July 2011
Target sample size: 42
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02499341
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Greece
Contacts
Name:     Paraskevi Matsota, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Attikon University Hospital, Athens, Greece
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Postoperative Pain
Intervention(s)
Drug: Tramadol
Drug: Ketamine
Primary Outcome(s)
Measurement of morphine consumption expressed as milligrams postoperatively in abdominal surgery. [Time Frame: 48 hours postoperatively]
Secondary Outcome(s)
Secondary ID(s)
637
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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