Ketamine Improves Post-Thoracotomy Analgesia

This study has been completed.
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: February 8, 2008
Last updated: February 28, 2008
Last verified: February 2008
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hemodynamic and respiratory parameters, side effects [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

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.


Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier (NCT Number):
Responsible Party: Avi A Weinbroum, MD, Tel Aviv Sourasky Medical Center Identifier: NCT00625911     History of Changes
Other Study ID Numbers: TASMC-01-AW-114-CTIL 
Study First Received: February 8, 2008
Last Updated: February 28, 2008
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Pain, Postoperative
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Analgesics, Opioid
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016