The Effect of Pregabalin on Pain of Propofol Injection

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Lidocaine; Drug: Pregabalin; Drug: propofol

• Registration Number: NCT02668094
• Lead Sponsor: Kyungpook National University Hospital

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2016-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patient underwent elective dental surgery.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	propofol	Lidocaine 40mg was given intravenously before injection of propofol
Group L	Lidocaine	Lidocaine 40mg was given intravenously before injection of propofol
Group LP	Pregabalin	Pregabalin 75 mg was given orally 2 hour before surgery
Group LP	propofol	Pregabalin 75 mg was given orally 2 hour before surgery
Group HP	Pregabalin	Pregabalin 150 mg was given orally 2 hour before surgery
Group HP	propofol	Pregabalin 150 mg was given orally 2 hour before surgery

Primary Outcome Measures

Name	Time	Method
Propofol injection pain	10 seconds after injection of propofol	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).

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of