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Ketamine Improves Post-Thoracotomy Analgesia

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ClinicalTrials.gov Identifier: NCT00625911
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : February 29, 2008
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE February 8, 2008
First Posted Date  ICMJE February 29, 2008
Last Update Posted Date February 29, 2008
Study Start Date  ICMJE September 2001
Actual Primary Completion Date March 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
pain score [ Time Frame: 4 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2008)
hemodynamic and respiratory parameters, side effects [ Time Frame: 4 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Improves Post-Thoracotomy Analgesia
Official Title  ICMJE Ketamine Improves Post-Thoracotomy Analgesia
Brief Summary Thoracotomy for lung tumor or for minimally invasive direct coronary artery bypass (MIDCAB) surgery, may be associated with debilitating pain. Ketamine was shown to enhance opioid antinociception and prevent opioid resistance. We hypothesize that ketamine given with morphine would lower morphine consumption and narcotic related side effects after thoracotomy and provide superior analgesia to morphine given alone.
Detailed Description

We planned a prospective, randomomized, double blind study of 2 pain management protocols in consecutive patients undergoing thoracotomy for MIDCAB or lung tumor resection over a 6 month period. After patients emerged from a standardized general anesthetic and when objectively awake and complaining of pain >5/10 on a visual analogue pain scale, they were connected to an intravenous patient controlled analgesia regimen. The regimen was assigned randomly to be either morphine alone (1.5 mg per dose, lockout interval of 7 minutes) or morphine plus ketamine (1.0 mg morphine plus 5 mg ketamine per dose, same lockout interval). Rescue diclofenac was available to both groups. Follow-up lasted 4 hours.

We planned to monitor and compare pain scores, wakefulness scores, hemodynamic and respiratory parameters as well as total morphine consumption and incidence of side effects and complications. All monitoring and recording was done by blinded nurses and intensive care physicians.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post Operative Pain
Intervention  ICMJE
  • Drug: morphine
    intravenous patient controlled analgesia, standard protocol
  • Drug: morphine ketamine
    low dose ketamine added to 2/3 standard dose of morphine
    Other Name: ketalar
Study Arms  ICMJE
  • Active Comparator: morphine only
    standard analgesia protocol
    Intervention: Drug: morphine
  • Experimental: morphine ketamine
    alterantive regimen for intravenous patient controlled analgesia
    Intervention: Drug: morphine ketamine
Publications * Nesher N, Ekstein MP, Paz Y, Marouani N, Chazan S, Weinbroum AA. Morphine with adjuvant ketamine vs higher dose of morphine alone for immediate postthoracotomy analgesia. Chest. 2009 Jul;136(1):245-252. doi: 10.1378/chest.08-0246. Epub 2008 Aug 27.

*   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: February 28, 2008)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2002
Actual Primary Completion Date March 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consecutive patients scheduled for elective minimally invasive direct coronary artery bypass (MIDCAB) or for lung resection via anterolateral thoracotomy during a 6-month period (Sep 2001-March 2002)

Exclusion Criteria:

Exclusion criteria were:

  • American Society of Anesthesiologists (ASA) physical class ≥3, Emergency operations,
  • Q-wave myocardial infarct occurring during the previous 3 weeks, or poor left ventricular function (e.g., ejection fraction [EF] <30% by echocardiography or angiography).

Other exclusion criteria were:

  • A body mass index >35 kg/m2,
  • Past or current neuropathy or psychological disturbances,
  • The use of centrally active drugs,
  • Chronic liver or renal failure requiring dialysis,
  • A FEV1/FVC <70%,
  • Allergy to ketamine, morphine or non steroidal anti inflammatory drugs (NSAIDs),
  • Clotting abnormalities,
  • A platelets count <70000/mm3,
  • A white blood count <3000>14000/mm3,
  • Uncontrolled diabetes mellitus or fasting blood glucose >250 g/dl,
  • Evidence of sepsis or infection up to one week prior to randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, 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 Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625911
Other Study ID Numbers  ICMJE TASMC-01-AW-114-CTIL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avi A Weinbroum, MD, Tel Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Avi A Weinbroum, MD Tel-Aviv Sourasky Medical Center
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date February 2008

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