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Ketamine Improves Post-Thoracotomy Analgesia
This study has been completed.
Study NCT00625911   Information provided by Tel-Aviv Sourasky Medical Center
First Received: February 8, 2008   Last Updated: February 28, 2008   History of Changes

February 8, 2008
February 28, 2008
September 2001
March 2002   (final data collection date for primary outcome measure)
pain score [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00625911 on ClinicalTrials.gov Archive Site
hemodynamic and respiratory parameters, side effects [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
Same as current
 
Ketamine Improves Post-Thoracotomy Analgesia
Ketamine Improves Post-Thoracotomy Analgesia

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.

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.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Post Operative Pain
  • Drug: morphine
  • Drug: morphine ketamine
  • Active Comparator: standard analgesia protocol
  • Experimental: alterantive regimen for intravenous patient controlled analgesia
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):245-52. Epub 2008 Aug 27.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
44
March 2002
March 2002   (final data collection date for primary outcome measure)

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.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00625911
Avi A Weinbroum, MD, Tel Aviv Sourasky Medical Center
TASMC-01-AW-114-CTIL
Tel-Aviv Sourasky Medical Center
 
Principal Investigator: Avi A Weinbroum, MD Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
February 2008

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