Ketamine Improves Post-Thoracotomy Analgesia
N/A
N/A
Both
Post Operative Pain
Trial Information
Ketamine Improves Post-Thoracotomy Analgesia
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.
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.
Type of Study:
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
Outcome Measure:
pain score
Outcome Time Frame:
4 hours
Safety Issue:
No
Principal Investigator
Avi A Weinbroum, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tel-Aviv Sourasky Medical Center
Authority:
Israel: Ministry of Health
Study ID:
TASMC-01-AW-114-CTIL
NCT ID:
NCT00625911
Start Date:
September 2001
Completion Date:
March 2002
Related Keywords:
- Post Operative Pain
- thoracotomy
- minimally invasive direct coronary artery bypass
- ketamine
- pain
- Pain, Postoperative
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