The Effect of Pregabalin on Pain of Propofol Injection
1 other identifier
interventional
120
1 country
1
Brief Summary
Pain is a common side effect of propofol injection. The purpose of this study was to compare the efficacy of pregabalin and lidocaine in reducing propofol injection pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Feb 2016
Shorter than P25 for not_applicable pain
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
January 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMay 11, 2016
May 1, 2016
29 days
January 22, 2016
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Propofol injection pain
Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
10 seconds after injection of propofol
Study Arms (3)
Group L
ACTIVE COMPARATORLidocaine 40mg was given intravenously before injection of propofol
Group LP
ACTIVE COMPARATORPregabalin 75 mg was given orally 2 hour before surgery
Group HP
ACTIVE COMPARATORPregabalin 150 mg was given orally 2 hour before surgery
Interventions
Eligibility Criteria
You may qualify if:
- Patient underwent elective dental surgery.
You may not qualify if:
- Patient with a history of adverse response to lidocaine or pregabalin,
- Patient with cardiovascular or respiratory disease,
- Patient who takes any sedatives, analgesics, or anticonvulsants within 24 hours before surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyungpook National University Hospital
Daegu, 700-721, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Younghoon Jeon, Dr
Kyungpook National Hosptial
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 22, 2016
First Posted
January 29, 2016
Study Start
February 1, 2016
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
May 11, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share