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Ketamine for Analgesia After Cesarean Section

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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

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.

Condition or disease Intervention/treatment Phase
Cesarean Section Postoperative Pain Drug: 0.25 mg/kg of Ketamine Drug: 20ml of normal saline solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Ketamine for Analgesia After Cesarean Section
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketamine Group
Patients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia
Drug: 0.25 mg/kg of Ketamine
patients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia

Placebo Comparator: Placebo Group Drug: 20ml of normal saline solution
20ml of normal saline solution intravenously 5 minutes after spinal anesthesia




Primary Outcome Measures :
  1. Dynamic Visual Analog Scale [ Time Frame: 24 hours after cesarean section ]
    Pain score VAS range from 0 to 10, high scores mean worse outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   including only female patients undergoing cesarean section
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545801


Locations
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Tunisia
Mongi Slim University Hospital
La Marsa, Tunis, Tunisia, 2046
Sponsors and Collaborators
Mongi Slim Hospital
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Responsible Party: Mhamed Sami Mebazaa, Professor, head of department of anesthesia and critical care, Mongi Slim Hospital
ClinicalTrials.gov Identifier: NCT04545801    
Other Study ID Numbers: ketamine cesarean
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action