Ketamine Improves Post-Thoracotomy Analgesia

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

Tracking Information

• First Submitted Date: February 8, 2008
• First Posted Date: February 29, 2008
• Last Update Posted Date: February 29, 2008
• Study Start Date: September 2001
• Actual Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 28, 2008): pain score [ Time Frame: 4 hours ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: February 28, 2008): hemodynamic and respiratory parameters, side effects [ Time Frame: 4 hours ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine Improves Post-Thoracotomy Analgesia
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Post Operative Pain

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2008): 44
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2002
• Actual Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00625911
• Other Study ID Numbers: TASMC-01-AW-114-CTIL
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Avi A Weinbroum, MD, Tel Aviv Sourasky Medical Center
• Study Sponsor: Tel-Aviv Sourasky Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Avi A Weinbroum, MD; Tel-Aviv Sourasky Medical Center

• PRS Account: Tel-Aviv Sourasky Medical Center
• Verification Date: February 2008