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CompletedNCT02668094Updated May 11, 2016

The Effect of Pregabalin on Pain of Propofol Injection

An interventional study of Lidocaine and Pregabalin in Pain, sponsored by Kyungpook National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-05-11.

Sponsored by Kyungpook National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Pain

Keywords

  • propofol
  • lidocaine
  • pregabalin
03

In context

Lead sponsor

Kyungpook National University Hospital is the lead sponsor of 76 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient underwent elective dental surgery.

Exclusion criteria

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Group L

    Lidocaine 40mg was given intravenously before injection of propofol

    Drug: Lidocaine · Drug: propofol

  • Active comparator
    Group LP

    Pregabalin 75 mg was given orally 2 hour before surgery

    Drug: Pregabalin · Drug: propofol

  • Active comparator
    Group HP

    Pregabalin 150 mg was given orally 2 hour before surgery

    Drug: Pregabalin · Drug: propofol

Interventions

  • DrugLidocaine
  • DrugPregabalin
  • Drugpropofol
06

What researchers measure

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).

    Time frame: 10 seconds after injection of propofol

07

Study locations

1 site
  • Kyungpook National University Hospital
    Daegu, 700-721, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02668094
Lead sponsor
Kyungpook National University Hospital
Responsible party
Younghoon Jeon (Professor, Kyungpook National University Hospital) — Principal investigator
First posted
Jan 29, 2016
Start date
Feb 2016
Primary completion
Mar 2016
Completion
Mar 2016
Last update
May 11, 2016

Study contacts

Younghoon Jeon, Dr
principal investigator · Kyungpook National Hosptial

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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