Back to resultsEscalating Ketamine Doses and Pre-emption
Primary Purpose
Postoperative Pain Management
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ketamine
ketamine
ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain Management focused on measuring Preemption, ketamine, escalating, dose, pain, analgesia
Eligibility 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
Sites / Locations
- Tel Aviv Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Set 1
set 2
set 3
Arm Description
group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS)
2nd set received ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group
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
Outcomes
Primary Outcome Measures
postoperative pain
Secondary Outcome Measures
opioid drug consumption
Full Information
NCT ID
NCT01070108
First Posted
February 16, 2010
Last Updated
February 16, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01070108
Brief Title
Escalating Ketamine Doses and Pre-emption
Official Title
EARLY PREOPERATIVE ESCALATING DOSES OF KETAMINE ATTENUATE POSTOPERATIVE PAIN AND REDUCE MORPHINE CONSUMPTION IN HUMANS
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Management
Keywords
Preemption, ketamine, escalating, dose, pain, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Set 1
Arm Type
Active Comparator
Arm Description
group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS)
Arm Title
set 2
Arm Type
Active Comparator
Arm Description
2nd set received ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group
Arm Title
set 3
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS)
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Description
ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Description
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
Primary Outcome Measure Information:
Title
postoperative pain
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
opioid drug consumption
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
21722959
Citation
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.
Results Reference
derived
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Escalating Ketamine Doses and Pre-emption
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