Ketamine Improves Post-Thoracotomy Analgesia - Full Text View

Sponsor:	Tel-Aviv Sourasky Medical Center
Information provided by:	Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT00625911

Purpose

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ketamine Improves Post-Thoracotomy Analgesia

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

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
morphine only: Active Comparator standard analgesia protocol	Drug: morphine intravenous patient controlled analgesia, standard protocol
morphine ketamine: Experimental alterantive regimen for intravenous patient controlled analgesia	Drug: morphine ketamine low dose ketamine added to 2/3 standard dose of morphine

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625911

Locations

Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64238

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator:

Avi A Weinbroum, MD

Tel-Aviv Sourasky Medical Center

More Information

No publications provided by Tel-Aviv Sourasky Medical Center

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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):245-52. Epub 2008 Aug 27.

Responsible Party:	Tel Aviv Sourasky Medical Center ( Avi A Weinbroum, MD )
Study ID Numbers:	TASMC-01-AW-114-CTIL
Study First Received:	February 8, 2008
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00625911 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:

thoracotomy
minimally invasive direct coronary artery bypass
ketamine
pain

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Pain
Excitatory Amino Acid Agents
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Ketamine
Analgesics
Pain, Postoperative

Analgesics, Opioid
Excitatory Amino Acid Antagonists
Anesthetics, Intravenous
Morphine
Central Nervous System Depressants
Narcotics
Anesthetics, Dissociative
Pharmacologic Actions
Postoperative Complications
Anesthetics, General
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009