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| Tracking Information | |||||
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| First Received Date ICMJE | February 8, 2008 | ||||
| Last Updated Date | February 28, 2008 | ||||
| Start Date ICMJE | September 2001 | ||||
| Primary Completion Date | March 2002 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
pain score [ Time Frame: 4 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00625911 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
hemodynamic and respiratory parameters, side effects [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ketamine Improves Post-Thoracotomy Analgesia | ||||
| Official Title ICMJE | Ketamine Improves Post-Thoracotomy Analgesia | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Post Operative Pain | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 44 | ||||
| Completion Date | March 2002 | ||||
| Primary Completion Date | March 2002 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Exclusion criteria were:
Other exclusion criteria were:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00625911 | ||||
| Responsible Party | Avi A Weinbroum, MD, Tel Aviv Sourasky Medical Center | ||||
| Study ID Numbers ICMJE | TASMC-01-AW-114-CTIL | ||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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