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.

Intervention / Treatment

  • S(+)-ketamine (DRUG)
    S(+)-Ketamine 0,3mg/kg/hr intraoperative

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 4
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 42 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jun 01, 2012
    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

    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

    • 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.

    Eligibility Criteria

    Sex: All
    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.

    Primary Outcomes
    • Morphine consumption 12 hours

    More Details

    NCT Number: NCT02421913
    Other IDs: CMCampinas
    Study URL: https://clinicaltrials.gov/study/NCT02421913
    Last updated: Sep 29, 2023