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Ketamine Improves Post-Thoracotomy Analgesia

NCT ID: NCT00625911

Last Updated: 2008-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2002-03-31

Brief Summary

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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

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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.

Conditions

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Post Operative Pain

Keywords

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thoracotomy minimally invasive direct coronary artery bypass ketamine pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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morphine only

standard analgesia protocol

Group Type ACTIVE_COMPARATOR

morphine

Intervention Type DRUG

intravenous patient controlled analgesia, standard protocol

morphine ketamine

alterantive regimen for intravenous patient controlled analgesia

Group Type EXPERIMENTAL

morphine ketamine

Intervention Type DRUG

low dose ketamine added to 2/3 standard dose of morphine

Interventions

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morphine

intravenous patient controlled analgesia, standard protocol

Intervention Type DRUG

morphine ketamine

low dose ketamine added to 2/3 standard dose of morphine

Intervention Type DRUG

Other Intervention Names

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ketalar

Eligibility Criteria

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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

* 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).


* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel Aviv Sourasky Medical Center

Principal Investigators

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Avi A Weinbroum, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 18753471 (View on PubMed)

Other Identifiers

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TASMC-01-AW-114-CTIL

Identifier Type: -

Identifier Source: org_study_id