The Effect of Pregabalin on Pain of Propofol Injection

Pain Clinical Trial

Official title:

The Effect of Pregabalin on Pain of Propofol Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668094
• Other study ID #: 2015-03-037-001
• Status: Completed
• Phase: N/A
• First received: January 22, 2016
• Last updated: May 10, 2016
• Start date: February 2016
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

In a randomized, double blind, prospective trial, 120 patients were allocated to one of three groups (each n=40) receiving intravenous lidocaine 40mg (group L), oral pregabalin 75 mg (group LP), and oral pregabalin 150 mg (group HP) as pretreatment, followed by injection of 25% of 2 mg/kg propofol. Pain was assessed by a four point scale (0=no, 1=mild, 2=moderate, 3=severe pain).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient underwent elective dental surgery.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine

• Pregabalin

• propofol

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No