Ketamine for Analgesia After Cesarean Section

Postoperative Pain Clinical Trial

Official title:

Ketamine for Analgesia After Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04545801
• Other study ID #: ketamine cesarean
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2020
• Source: Mongi Slim Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Tunisia	Mongi Slim University Hospital	La Marsa	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Visual Analog Scale	Pain score VAS range from 0 to 10, high scores mean worse outcome	24 hours after cesarean section