Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain
1 other identifier
interventional
118
1 country
1
Brief Summary
Propofol remains the most common drug for induction of general anaesthesia, although it causes considerable pain or discomfort on injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. No studies to date have looked at the dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of propofol related pain on injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2014
Shorter than P25 for phase_4
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
First Submitted
Initial submission to the registry
November 1, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 21, 2015
November 1, 2014
5 months
November 1, 2014
April 18, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Verbal Pain Score
Approximately one minute following administration of propofol.
Facial Pain Score
Approximately one minute following administration of propofol.
Study Arms (3)
saline
PLACEBO COMPARATORdexketoprofen
ACTIVE COMPARATORtenoxicam
ACTIVE COMPARATORInterventions
before the anesthesia induction, 2mL saline iv injection
before the anesthesia induction, 50 mg (2mL) iv dexketoprofen
before the anesthesia induction, 20 mg (2mL) iv tenoxicam
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists (ASA) physical status 1 and 2
- years
- general anesthesia scheduled for elective surgery
You may not qualify if:
- age \< 18 years, \> 65 years
- pregnancy
- patients requiring a rapid sequence induction
- refusal to participate and patients already participating in another study
- allergy to study drugs
- communication difficulty
- psychiatric and neurolojic disorders
- use of analgesics or sedative drugs within 24 hours before surgery.
- emergency surgery
- history of drug or alcohol abuse
- ASA 3 and above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ordu Universitylead
Study Sites (1)
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
Altinordu, Ordu, 52100, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, assistant professor
Study Record Dates
First Submitted
November 1, 2014
First Posted
November 7, 2014
Study Start
November 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
April 21, 2015
Record last verified: 2014-11