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Ketamine Improves Post-Thoracotomy Analgesia

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
morphine
morphine ketamine
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring thoracotomy, minimally invasive direct coronary artery bypass, ketamine, pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

morphine only

morphine ketamine

Arm Description

standard analgesia protocol

alterantive regimen for intravenous patient controlled analgesia

Outcomes

Primary Outcome Measures

pain score

Secondary Outcome Measures

hemodynamic and respiratory parameters, side effects

Full Information

First Posted
February 8, 2008
Last Updated
February 28, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00625911
Brief Title
Ketamine Improves Post-Thoracotomy Analgesia
Official Title
Ketamine Improves Post-Thoracotomy Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
March 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
thoracotomy, minimally invasive direct coronary artery bypass, ketamine, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
morphine only
Arm Type
Active Comparator
Arm Description
standard analgesia protocol
Arm Title
morphine ketamine
Arm Type
Experimental
Arm Description
alterantive regimen for intravenous patient controlled analgesia
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
intravenous patient controlled analgesia, standard protocol
Intervention Type
Drug
Intervention Name(s)
morphine ketamine
Other Intervention Name(s)
ketalar
Intervention Description
low dose ketamine added to 2/3 standard dose of morphine
Primary Outcome Measure Information:
Title
pain score
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
hemodynamic and respiratory parameters, side effects
Time Frame
4 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avi A Weinbroum, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64238
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
18753471
Citation
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.
Results Reference
derived

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Ketamine Improves Post-Thoracotomy Analgesia

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