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A Comparison Study Between Ketamine Versus Tramadol for Pain Management After Major Upper Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT02499341
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
Paraskevi Matsota, Attikon Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Tramadol Drug: Ketamine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison Between Ketamine and Tramadol for Pain Management After Major Upper Abdominal Surgery
Study Start Date : July 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tramadol
Intraoperative administration of a bolus dose of tramadol and continuous intravenous infusion of tramadol for up to 48 h postoperatively.
Drug: Tramadol
Tramadol administered intravenously (1mg/kg) thirty minutes before the expected end of surgery, followed by a continuous infusion of tramadol (0.2mg•kg-¹•h-¹) for up to 48 h after major upper abdominal surgery, in patients receiving PCA morphine postoperatively at a bolus dose of 1 mg with a lockout period of 8 minutes.
Other Name: Tramal

Active Comparator: Ketamine
Intraoperative administration of a bolus dose of ketamine and continuous intravenous infusion of ketamine for up to 48 h postoperatively.
Drug: Ketamine
Ketamine administered intravenously (0.5mg/kg) thirty minutes before the expected end of surgery, followed by a continuous infusion of ketamine (0.12mg•kg-¹•h-¹) for up to 48 h after major upper abdominal surgery, in patients receiving PCA morphine postoperatively at a bolus dose of 1 mg with a lockout period of 8 minutes.
Other Name: Ketalar




Primary Outcome Measures :
  1. Measurement of morphine consumption expressed as milligrams postoperatively in abdominal surgery. [ Time Frame: 48 hours postoperatively ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499341


Locations
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Greece
2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attiki, Greece, 12462
Sponsors and Collaborators
Attikon Hospital
Investigators
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Principal Investigator: Paraskevi Matsota, MD, PhD Attikon University Hospital, Athens, Greece

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Responsible Party: Paraskevi Matsota, Professor of Anesthesiology, MD, PhD, Attikon Hospital
ClinicalTrials.gov Identifier: NCT02499341     History of Changes
Other Study ID Numbers: 637
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: June 2015

Keywords provided by Paraskevi Matsota, Attikon Hospital:
Tramadol
Ketamine
Morphine

Additional relevant MeSH terms:
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Tramadol
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Ketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action