Ketamine Improves Post-Thoracotomy Analgesia
Information source: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Operative Pain
Intervention: morphine (Drug); morphine ketamine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Tel-Aviv Sourasky Medical Center Official(s) and/or principal investigator(s):
Avi A Weinbroum, MD, Principal Investigator, Affiliation: Tel-Aviv Sourasky Medical Center
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.
Clinical Details
Official title: Ketamine Improves Post-Thoracotomy Analgesia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: pain score
Secondary outcome: hemodynamic and respiratory parameters, side effects
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Tel Aviv Sourasky Medical Center, Tel Aviv 64238, Israel
Additional Information
Starting date: September 2001
Last updated: February 28, 2008
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