Escalating Ketamine Doses and Pre-emption

This study has been completed.

Sponsor:

Information provided by:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT01070108

First received: February 16, 2010

Last updated: NA

Last verified: February 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 16, 2010
Last Updated Date	February 16, 2010
Start Date ^ICMJE	January 2007
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 16, 2010)	postoperative pain [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: February 16, 2010)	opioid drug consumption [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Escalating Ketamine Doses and Pre-emption
Official Title ^ICMJE	EARLY PREOPERATIVE ESCALATING DOSES OF KETAMINE ATTENUATE POSTOPERATIVE PAIN AND REDUCE MORPHINE CONSUMPTION IN HUMANS
Brief Summary	Ketamine affects postoperative pain when administered intravenously immediately before, during or at the end of surgical procedures. We assessed the effects of multiple and escalating doses of ketamine administered many hours before surgery on postoperative pain and analgesia consumption.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Postoperative Pain Management
Intervention ^ICMJE	Drug: Ketamine group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS) Drug: ketamine ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group Drug: ketamine ketamine injected IM 17-18, 11-12, and 3-4 hours before surgery (5, 10 and 25 mg, respectively) (K3), and the second group received NS
Study Arm (s)	Active Comparator: Set 1 group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS) Interventions: Drug: Ketamine Drug: ketamine Drug: ketamine Active Comparator: set 2 2nd set received ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group Interventions: Drug: ketamine Drug: ketamine Active Comparator: set 3 3rd set one group had ketamine injected IM 17-18, 11-12, and 3-4 hours before surgery (5, 10 and 25 mg, respectively) (K3), and the second group received NS Intervention: Drug: ketamine
Publications *	Rakhman E, Shmain D, White I, Ekstein MP, Kollender Y, Chazan S, Dadia S, Bickels J, Amar E, Weinbroum AA. Repeated and escalating preoperative subanesthetic doses of ketamine for postoperative pain control in patients undergoing tumor resection: a randomized, placebo-controlled, double-blind trial. Clin Ther. 2011 Jul;33(7):863-73. Epub 2011 Jul 1.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	January 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Consecutive patients, who were scheduled to undergo general or orthopedic oncologic surgery under general anesthesia Exclusion Criteria: allergy to opioids, ketamine or non-steroidal anti-inflammatory drugs (NSAIDs) history of lasting chronic pain or psychiatric disorders or had used opioids or psychotropic drugs of any sort during the past two weeks soldiers and pregnant women
Gender	Both
Ages	15 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01070108
Other Study ID Numbers ^ICMJE	ketamine
Has Data Monitoring Committee	No
Responsible Party	Weinbroum Avraham, Tel Aviv Medical Center
Study Sponsor ^ICMJE	Tel-Aviv Sourasky Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Tel-Aviv Sourasky Medical Center
Verification Date	February 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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