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Ketamine for Analgesia After Cesarean Section

Primary Purpose

Cesarean Section, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
0.25 mg/kg of Ketamine
20ml of normal saline solution
Sponsored by
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mongi Slim University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketamine Group

Placebo Group

Arm Description

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

Outcomes

Primary Outcome Measures

Dynamic Visual Analog Scale
Pain score VAS range from 0 to 10, high scores mean worse outcome

Secondary Outcome Measures

Full Information

First Posted
September 4, 2020
Last Updated
September 12, 2020
Sponsor
Mongi Slim Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04545801
Brief Title
Ketamine for Analgesia After Cesarean Section
Official Title
Ketamine for Analgesia After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine Group
Arm Type
Active Comparator
Arm Description
Patients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
0.25 mg/kg of Ketamine
Intervention Description
patients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
20ml of normal saline solution
Intervention Description
20ml of normal saline solution intravenously 5 minutes after spinal anesthesia
Primary Outcome Measure Information:
Title
Dynamic Visual Analog Scale
Description
Pain score VAS range from 0 to 10, high scores mean worse outcome
Time Frame
24 hours after cesarean section

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
including only female patients undergoing cesarean section
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mongi Slim University Hospital
City
La Marsa
State/Province
Tunis
ZIP/Postal Code
2046
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ketamine for Analgesia After Cesarean Section

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