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Ketamine Improves Post-Thoracotomy Analgesia

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 29, 2008
Last Update Posted: February 29, 2008
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.
Information provided by:
Tel-Aviv Sourasky Medical Center
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.

Condition Intervention
Post Operative Pain Drug: morphine Drug: morphine ketamine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine Improves Post-Thoracotomy Analgesia

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • pain score [ Time Frame: 4 hours ]

Secondary Outcome Measures:
  • hemodynamic and respiratory parameters, side effects [ Time Frame: 4 hours ]

Enrollment: 44
Study Start Date: September 2001
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: morphine only
standard analgesia protocol
Drug: morphine
intravenous patient controlled analgesia, standard protocol
Experimental: morphine ketamine
alterantive regimen for intravenous patient controlled analgesia
Drug: morphine ketamine
low dose ketamine added to 2/3 standard dose of morphine
Other Name: ketalar

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.


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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): NCT00625911

Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64238
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Avi A Weinbroum, MD Tel-Aviv Sourasky Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Avi A Weinbroum, MD, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00625911     History of Changes
Other Study ID Numbers: TASMC-01-AW-114-CTIL
First Submitted: February 8, 2008
First Posted: February 29, 2008
Last Update Posted: February 29, 2008
Last Verified: February 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
minimally invasive direct coronary artery bypass

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