Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
S(+)-Ketamine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- 18 Years to 65 Years ASA I and II Accepts healthy volunteers.
Exclusion Criteria:
alcohol or illicit drugs, H2 inhibitors, opioids, or calcium-channel blockers within the last 10 days chronic pain, myocardial ischemia, psychiatric diseases.
Sites / Locations
- Centro Médico Campinas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
S(+)-ketamine group (SG)
placebo group (PG)
Arm Description
Five minutes before surgery, patients in the SG group received an intravenous continuous infusion containing 0.3 mg.kg-1.h-1 of S(+)-ketamine
PG received the same dose of saline.
Outcomes
Primary Outcome Measures
Morphine consumption
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02421913
Brief Title
Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain
Official Title
Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Medico Campinas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Methods: This is a double-blind randomized controlled trial with 48 patients of both genders aged from 18 to 65 years who underwent videolaparoscopic cholecystectomy. After venipuncture, patients received intravenous parecoxib sodium (40 mg). Target-controlled intravenous anesthesia was induced with propofol and remifentanil associated with rocuronium and adjusted to maintain the bispectral index between 35 and 50. The S(+)-ketamine group (SG) group received a continuous infusion of S(+)-ketamine at a dose of 0.3mg.kg-1.h-1, while the placebo group (PG) received a continuous infusion of saline at the same dose. Postoperative analgesia was measured by a verbal numerical scale (VNS) from 0 to 10 during 12 hours and treated with morphine when VNS score was equal to or higher than 3 at a dose of 0.05 mg.kg-1 when the patient reported pain for the first time and at a dose of 0.025mg.kg-1 on subsequent occasions. Pain scores were recorded in the postoperative care unit (PACU) and at 4 and 12 hours after the end of the surgery The amount of morphine used during PACU stay, from PACU discharge to 4 hours after surgery, and from 4 to 12 hours after surgery, the overall dose of morphine used, and possible adverse effects were also assessed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S(+)-ketamine group (SG)
Arm Type
Active Comparator
Arm Description
Five minutes before surgery, patients in the SG group received an intravenous continuous infusion containing 0.3 mg.kg-1.h-1 of S(+)-ketamine
Arm Title
placebo group (PG)
Arm Type
Placebo Comparator
Arm Description
PG received the same dose of saline.
Intervention Type
Drug
Intervention Name(s)
S(+)-Ketamine
Intervention Description
S(+)-Ketamine 0,3mg/kg/hr intraoperative
Primary Outcome Measure Information:
Title
Morphine consumption
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 Years to 65 Years ASA I and II Accepts healthy volunteers.
Exclusion Criteria:
alcohol or illicit drugs, H2 inhibitors, opioids, or calcium-channel blockers within the last 10 days chronic pain, myocardial ischemia, psychiatric diseases.
Facility Information:
Facility Name
Centro Médico Campinas
City
Campinas
State/Province
SP
ZIP/Postal Code
13083190
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
15983467
Citation
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.
Results Reference
background
PubMed Identifier
23254146
Citation
Untergehrer 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.
Results Reference
background
PubMed Identifier
26949390
Citation
Miziara 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.
Results Reference
derived
Learn more about this trial
Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain
We'll reach out to this number within 24 hrs