Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain
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.
Condition or Disease
- Postoperative Pain
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 18 Years to 65 Years |
Enrollment: | 42 (ACTUAL) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Prevention |
MaskingTRIPLE:
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Clinical Trial Dates
Start date: | Jun 01, 2012 | |
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Primary Completion: | Feb 01, 2014 | ACTUAL |
Completion Date: | Feb 01, 2015 | ACTUAL |
Study First Posted: | Apr 21, 2015 | ESTIMATED |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Apr 21, 2015 |
Sponsors / Collaborators
Lead Sponsor:
Centro Medico Campinas
Responsible Party:
N/A
Location
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
Participant Groups
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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
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PG received the same dose of saline.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 18 |
Maximum Age: | 65 |
Age Groups: | Adult / Older Adult |
Healthy Volunteers: | Yes |
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.
* 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.
Primary Outcomes
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Morphine consumption 12 hours
More Details
NCT Number: | NCT02421913 |
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Other IDs: | CMCampinas |
Study URL: | https://clinicaltrials.gov/study/NCT02421913 |
Last updated: Sep 29, 2023