Intravenous Ketamine and Postoperative Pain Following Cesarean Section.
Effect of Single Intravenous Ketamine Dose on Postoperative Pain Following Cesarean Section Under Spinal Anesthesia: A Randomized Control Clinical Trial.
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to investigate the analgesic effect of low-dose intravenous ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 postoperative-pain
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 10, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJanuary 12, 2017
January 1, 2017
5 months
January 10, 2017
January 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
• Number of Subjects Requiring Supplemental Analgesia
24 hours postoperative
Secondary Outcomes (2)
Cumulative morphine/paracetamol
24 hours postoperative
Number of subjects reporting nausea, vomiting
24 hours postoperative
Study Arms (2)
Ketamine group
ACTIVE COMPARATORwill receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
Control group
PLACEBO COMPARATORwill receive intravenous 20 ml of normal saline, delivered over 10 minutes.
Interventions
will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
will receive intravenous 20 ml of normal saline, delivered over 10 minutes.
Eligibility Criteria
You may qualify if:
- Eligible women ASA class 1 and 2, are at term (≥37 week gestation), Scheduled for elective cesarean section whose anesthetic plan is for spinal anesthesia with Bupivacaine and intravenous pethidine and paracetamol for post operative analgesia.
You may not qualify if:
- Body mass index ≥40 kg/m2,
- Known allergy to any of the study medications,
- Contraindication to the spinal anesthesia,
- History of substance abuse,
- History of hallucinations,
- Chronic opioid therapy,
- Chronic pain.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university faculty of medicine
Asyut, Egypt
Related Publications (1)
El-Tahan MR, Warda OM, Yasseen AM, Attallah MM, Matter MK. A randomized study of the effects of preoperative ketorolac on general anaesthesia for caesarean section. Int J Obstet Anesth. 2007 Jul;16(3):214-20. doi: 10.1016/j.ijoa.2007.01.012. Epub 2007 Apr 24.
PMID: 17459695BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Israa M Sayed
Assiut University
Central Study Contacts
Hamdy A Yousef, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of anesthesia and ICU
Study Record Dates
First Submitted
January 10, 2017
First Posted
January 12, 2017
Study Start
January 1, 2017
Primary Completion
June 1, 2017
Study Completion
October 1, 2017
Last Updated
January 12, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share