Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain
1 other identifier
interventional
42
1 country
1
Brief Summary
Background: The use of low-dose continuous infusion of S(+)-ketamine combined with target-controlled intravenous anesthesia with remifentanil and propofol may be related to the control of postoperative pain and of opioid-induced hyperalgesia. The present study aimed to evaluate the efficacy of continuous infusion of S(+)-ketamine given intraoperatively in the control of postoperative pain compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 postoperative-pain
Started Jun 2012
Longer than P75 for phase_4 postoperative-pain
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
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 16, 2015
CompletedFirst Posted
Study publicly available on registry
April 21, 2015
CompletedApril 22, 2015
April 1, 2015
1.7 years
April 16, 2015
April 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Morphine consumption
12 hours
Study Arms (2)
S(+)-ketamine group (SG)
ACTIVE COMPARATORFive minutes before surgery, patients in the SG group received an intravenous continuous infusion containing 0.3 mg.kg-1.h-1 of S(+)-ketamine
placebo group (PG)
PLACEBO COMPARATORPG received the same dose of saline.
Interventions
Eligibility Criteria
You may qualify if:
- Years to 65 Years ASA I and II Accepts healthy volunteers.
You may not qualify if:
- alcohol or illicit drugs, H2 inhibitors, opioids, or calcium-channel blockers within the last 10 days chronic pain, myocardial ischemia, psychiatric diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Médico Campinas
Campinas, São Paulo, 13083190, Brazil
Related Publications (3)
Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.
PMID: 15983467BACKGROUNDUntergehrer G, Jordan D, Eyl S, Schneider G. Effects of propofol, sevoflurane, remifentanil, and (S)-ketamine in subanesthetic concentrations on visceral and somatosensory pain-evoked potentials. Anesthesiology. 2013 Feb;118(2):308-17. doi: 10.1097/ALN.0b013e318279fb21.
PMID: 23254146BACKGROUNDMiziara LE, Simoni RF, Esteves LO, Cangiani LH, Grillo-Filho GF, Paula AG. Efficacy of Continuous S(+)-Ketamine Infusion for Postoperative Pain Control: A Randomized Placebo-Controlled Trial. Anesthesiol Res Pract. 2016;2016:6918327. doi: 10.1155/2016/6918327. Epub 2016 Feb 2.
PMID: 26949390DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
April 16, 2015
First Posted
April 21, 2015
Study Start
June 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2015
Last Updated
April 22, 2015
Record last verified: 2015-04