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

Inonu University

Status and phase: Completed; Phase 4

Conditions: Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine

Treatments: Drug: Placebo (for alcalinized lidocaine); Drug: alkalinized lidocaine; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01773044

ulkü_1

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• undergoing elective surgery

Exclusion criteria

• allergy to the study drug

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

alkalinized lidocaine & lidocaine

Active Comparator group

Treatment:

Drug: Lidocaine

Drug: alkalinized lidocaine

alkalinized lidocaine &Placebo

Active Comparator group

Treatment:

Drug: Placebo (for alcalinized lidocaine)

Drug: alkalinized lidocaine