Escalating Ketamine Doses and Pre-emption

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ClinicalTrials.gov Identifier: NCT01070108

Recruitment Status : Completed

First Posted : February 17, 2010

Last Update Posted : February 17, 2010

Sponsor:

Information provided by:

Tel-Aviv Sourasky Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain Management	Drug: Ketamine Drug: ketamine	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	EARLY PREOPERATIVE ESCALATING DOSES OF KETAMINE ATTENUATE POSTOPERATIVE PAIN AND REDUCE MORPHINE CONSUMPTION IN HUMANS
Study Start Date :	January 2007
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Non-Drug Pain Management

Drug Information available for: Ketamine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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)	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
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	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
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	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

Outcome Measures

Primary Outcome Measures :

postoperative pain [ Time Frame: 48 hours ]

Secondary Outcome Measures :

opioid drug consumption [ Time Frame: 48 hours ]

Eligibility Criteria

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Ages Eligible for Study:	15 Years to 75 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070108

Locations

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Israel
Tel Aviv Medical Center
Tel Aviv, Israel

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1016/j.clinthera.2011.05.094. Epub 2011 Jul 1.

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Responsible Party:	Weinbroum Avraham, Tel Aviv Medical Center
ClinicalTrials.gov Identifier:	NCT01070108
Other Study ID Numbers:	ketamine
First Posted:	February 17, 2010 Key Record Dates
Last Update Posted:	February 17, 2010
Last Verified:	February 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:


Preemption, ketamine, escalating, dose, pain, analgesia

Additional relevant MeSH terms:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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