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
|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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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
- Dynamic Visual Analog Scale [ Time Frame: 24 hours after cesarean section ]Pain score VAS range from 0 to 10, high scores mean worse outcome
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
|Mongi Slim University Hospital|
|La Marsa, Tunis, Tunisia, 2046|