Escalating Ketamine Doses and Pre-emption
EARLY PREOPERATIVE ESCALATING DOSES OF KETAMINE ATTENUATE POSTOPERATIVE PAIN AND REDUCE MORPHINE CONSUMPTION IN HUMANS
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedFebruary 17, 2010
February 1, 2010
2 years
February 16, 2010
February 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pain
48 hours
Secondary Outcomes (1)
opioid drug consumption
48 hours
Study Arms (3)
Set 1
ACTIVE COMPARATORgroup receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS)
set 2
ACTIVE COMPARATOR2nd set received ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group
set 3
ACTIVE COMPARATOR3rd 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
Interventions
group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS)
Eligibility Criteria
You may qualify if:
- Consecutive patients, who were scheduled to undergo general or orthopedic oncologic surgery under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tel Aviv Medical Center
Tel Aviv, Israel
Related Publications (1)
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.
PMID: 21722959DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
January 1, 2007
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
February 17, 2010
Record last verified: 2010-02