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Completed

NCT Number: NCT01773044

Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine

Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain.

Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.

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Key information

Conditions

Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inonu university medicine faculty

Malatya, 44280, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • undergoing elective surgery

Exclusion criteria

  • allergy to the study drug

Treatment and study plan

Alkalinized lidocaine

Drug

recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)

Lidocaine

Drug

0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),

Placebo (for alcalinized lidocaine)

Drug

Primary outcomes

  1. Pain on injection of propofol

    Time frame: 5 th minutes after propofol injection

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 23, 2013
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.