We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Completed
First Posted : October 7, 2015
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University

Tracking Information
First Submitted Date  ICMJE October 5, 2015
First Posted Date  ICMJE October 7, 2015
Last Update Posted Date September 8, 2021
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2021)
Time to first trigger of morphine [ Time Frame: 24 hours ]
Time to first trigger of morphine
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Time to first trigger of morphine [ Time Frame: 24 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2021)
  • 24-hr morphine consumption [ Time Frame: 24 hours ]
    24-hr morphine consumption
  • NRS score at 6, 24 hours [ Time Frame: 24 hours ]
    NRS score (0-10) was assessed at at 6, 24 hours postoperative
  • Incidence of nausea and vomiting [ Time Frame: 24 hours ]
    Incidence of nausea and vomiting
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • 24-hr morphine consumption [ Time Frame: 24 hours ]
  • NRS score at 6, 24 hours [ Time Frame: 24 hours ]
  • Incidence of nausea and vomitting [ Time Frame: 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study
Official Title  ICMJE Low Dose Intraoperative Intravenous Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Postoperative Period
Intervention  ICMJE
  • Other: NSS
    NSS infusion
  • Drug: Ketamine
    Ketamine 0.2 mg/kg/hr intravenous infusion
Study Arms  ICMJE
  • Placebo Comparator: Control
    NSS infusion
    Intervention: Other: NSS
  • Experimental: Ketamine
    Ketamine 0.2 mg/kg/hr intravenous infusion
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2021)
32
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2015)
40
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02570230
Other Study ID Numbers  ICMJE SI2558
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Sirilak Suksompong, Mahidol University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mahidol University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sirilak Suksompong, MD Mahidol University
PRS Account Mahidol University
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP