NCT00625911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2001

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
Last Updated

February 29, 2008

Status Verified

February 1, 2008

Enrollment Period

6 months

First QC Date

February 8, 2008

Last Update Submit

February 28, 2008

Conditions

Post Operative Pain

Keywords

thoracotomyminimally invasive direct coronary artery bypassketaminepain

Outcome Measures

Primary Outcomes (1)

  • pain score

    4 hours

Secondary Outcomes (1)

  • hemodynamic and respiratory parameters, side effects

    4 hours

Study Arms (2)

morphine only

ACTIVE COMPARATOR

standard analgesia protocol

Drug: morphine

morphine ketamine

EXPERIMENTAL

alterantive regimen for intravenous patient controlled analgesia

Drug: morphine ketamine

Interventions

morphineDRUG

intravenous patient controlled analgesia, standard protocol

morphine only
morphine ketamineDRUG

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

Also known as: ketalar
morphine ketamine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64238, Israel

Location

Related Publications (1)

  • 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.

    PMID: 18753471DERIVED

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

MorphineKetamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Avi A Weinbroum, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 29, 2008

Study Start

September 1, 2001

Primary Completion

March 1, 2002

Study Completion

March 1, 2002

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

IL(1)