Ketamine for Analgesia After Cesarean Section

Ketamine

Brief Summary

In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

Intervention / Treatment

  • 0.25 mg/kg of Ketamine (DRUG)
    patients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia
  • 20ml of normal saline solution (DRUG)
    20ml of normal saline solution intravenously 5 minutes after spinal anesthesia

Condition or Disease

  • Cesarean Section
  • Postoperative Pain

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 80 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Jan 01, 2019 ACTUAL
    Primary Completion: Mar 31, 2019 ACTUAL
    Completion Date: Apr 30, 2019 ACTUAL
    Study First Posted: Sep 11, 2020 ACTUAL
    Last Updated: Sep 12, 2020

    Sponsors / Collaborators

    Lead Sponsor: Mongi Slim Hospital
    Responsible Party: N/A

    Location

    La Marsa, Tunis, Tunisia

    In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

    The patients were randomized in two groups:

    * Group Ketamine: these patients recieved 0.25 mg/kg of Ketamin intravenously 5 minutes after the spinal anesthesia.
    * Group Placebo: recieved 20 ml of normal saline solution intravenously 5 minutes after the spinal puncture.

    The investigators recorded intra demographic, intraoperative and post operative data.

    The main outcome was the analgesic score: the visual analog scale (VAS). dynamic VAS was also monitored at 24 hours post operatively.

    Participant Groups

    • Patients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia

    • No description provided

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * full term pregnant adult patients
    * Monofetal pregnancy
    * scheduled for urgent or elective cesarean section under spinal anesthesia

    Exclusion Criteria:

    * necessity of general anesthesia during the procedure
    * Post partum hemorrage

    Primary Outcomes

    • Pain score VAS range from 0 to 10, high scores mean worse outcome

    More Details

    NCT Number: NCT04545801
    Other IDs: ketamine cesarean
    Study URL: https://clinicaltrials.gov/study/NCT04545801
    Last updated: Sep 29, 2023