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Ketamine for Analgesia After Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545801
Recruitment Status : Completed
First Posted : September 11, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Mhamed Sami Mebazaa, Mongi Slim Hospital

Tracking Information
First Submitted Date  ICMJE September 4, 2020
First Posted Date  ICMJE September 11, 2020
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2020)
Dynamic Visual Analog Scale [ Time Frame: 24 hours after cesarean section ]
Pain score VAS range from 0 to 10, high scores mean worse outcome
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
Dynamic Visual Analog Scale [ Time Frame: 24 hours after cesarean section ]
Pain score VAS
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Analgesia After Cesarean Section
Official Title  ICMJE Ketamine for Analgesia After Cesarean Section
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Cesarean Section
  • Postoperative Pain
Intervention  ICMJE
  • Drug: 0.25 mg/kg of Ketamine
    patients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia
  • Drug: 20ml of normal saline solution
    20ml of normal saline solution intravenously 5 minutes after spinal anesthesia
Study Arms  ICMJE
  • Active Comparator: Ketamine Group
    Patients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia
    Intervention: Drug: 0.25 mg/kg of Ketamine
  • Placebo Comparator: Placebo Group
    Intervention: Drug: 20ml of normal saline solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2020)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: including only female patients undergoing cesarean section
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04545801
Other Study ID Numbers  ICMJE ketamine cesarean
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mhamed Sami Mebazaa, Mongi Slim Hospital
Study Sponsor  ICMJE Mongi Slim Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mongi Slim Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP