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Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02570230
Recruitment Status : Unknown
Verified September 2017 by Sirilak Suksompong, Mahidol University.
Recruitment status was:  Recruiting
First Posted : October 7, 2015
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University

Brief Summary:
Thoracotomy is one of the most painful operation. Continuous thoracic epidural or paravertebral analgesia are gold standard for postoperative pain. But both techniques require skills. Spinal morphine is alternative simple method with less efficacy. Adding low dose ketamine during intraoperative may be helpful in postoperative pain relief.

Condition or disease Intervention/treatment Phase
Pain Postoperative Period Other: NSS Drug: Ketamine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Dose Intraoperative Intravenous Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study
Actual Study Start Date : March 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: Control
NSS infusion
Other: NSS
NSS infusion

Experimental: Ketamine
Ketamine 0.2 mg/kg/hr intravenous infusion
Drug: Ketamine
Ketamine 0.2 mg/kg/hr intravenous infusion




Primary Outcome Measures :
  1. Time to first trigger of morphine [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 24-hr morphine consumption [ Time Frame: 24 hours ]
  2. NRS score at 6, 24 hours [ Time Frame: 24 hours ]
  3. Incidence of nausea and vomitting [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status 1-3
  • elective thoracotomy
  • can operate patient-controlled analgesia (PCA) machine

Exclusion Criteria:

patient with history of

  • allergy to morphine or ketamine
  • contraindicate to ketamine
  • remain intubated in the postoperative period

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): NCT02570230


Contacts
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Contact: Sirilak Suksompong, MD 66891534806 sirilak.suk@mahidol.ac.th

Locations
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Thailand
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompong, MD    6624113256    sirilak.suk@mahidol.ac.th   
Principal Investigator: Sirilak Suksompong, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Sirilak Suksompong, MD Mahidol University

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Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02570230    
Other Study ID Numbers: SI2558
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sirilak Suksompong, Mahidol University:
Thoracotomy
Postoperative pain
Ketamine
Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action