Use of Iv Tramadol and Ketamine for Prevention of Post Spinal Anesthesia Shivering
Frequency of Shivering Among Patient Treaed With IV Tramadol Versus Iv Ketamine in Prevention of Post Spinal Anesthesia Undergoing Cesarean Section: Rendomiced Control Trial
1 other identifier
interventional
250
1 country
3
Brief Summary
\*Ketamine:\* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response. \- \*Tramadol:\* Tramadol is a pain medication that can also help reduce shivering. It works by affecting the brain's temperature regulation centers, which helps to reduce the shivering response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2024
Shorter than P25 for phase_3
3 active sites
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
September 30, 2024
CompletedFirst Submitted
Initial submission to the registry
November 28, 2024
CompletedFirst Posted
Study publicly available on registry
December 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedDecember 9, 2024
December 1, 2024
3 months
November 28, 2024
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Shivering
Scale validated by crossley and mahajan Grade 0: No shivering Grade 1: Piloerection, peripheral vasoconstriction, peripheral cyanosis, or mild fasciculation of the face or neck, but no visible muscle activity Grade 2: Visible muscle activity in one muscle group Grade 3: Visible muscle activity in more than one muscle group Grade 4: Gross muscle activity involving the entire body
20 minutes to 12 hours
Study Arms (2)
Group K
ACTIVE COMPARATORGroup K receive Inj: ketamine
Group T
ACTIVE COMPARATORGroup T receive Inj: Tramadol
Interventions
Eligibility Criteria
You may qualify if:
- Pateint for elective cesarean section
- Age 18 to 40 years
- ASA 1 and 2
You may not qualify if:
- ASA 2 and 3
- Cesarean section requiring general anesthesia
- Hypersensitivity to Ketamine, Tramadol and Opiods
- History of cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Liaquat National Hospital and Medical College
Karachi, Sindh, 75500, Pakistan
Liaquat National Hospital and Medical College
Karachi, Sindh, Pakistan
Liaquat National Hospital and Medical College
Karachi, Sindh, Pakistan
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nazish Dr Nazish Kanwal
Liaquat national hospital and medical college
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 28, 2024
First Posted
December 9, 2024
Study Start
September 30, 2024
Primary Completion
December 30, 2024
Study Completion
January 30, 2025
Last Updated
December 9, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
Patient confidentiality\*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families. * Informed consent\*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns.