Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation
Condition: Pain
Intervention: normal saline; lidocaine; lidocaine
Intervention description: A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.; A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.; A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 2 Years
Maximum age: 7 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pain; propofol; lidocaine; sedation; pediatric

Summary:

      This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the
      effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term
      deep sedation in children. Patients will be randomized to receive either placebo (saline) or
      one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The
      efficacy of the differing lidocaine doses will be compared to determine the minimum dose
      required to safely achieve alleviation of pain. We hypothesize that premedicating with
      lidocaine will significantly decrease pain experienced by pediatric patients receiving
      propofol for outpatient sedation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  scheduled for painless diagnostic procedures

          -  are ASA I or ASA II

        Exclusion Criteria:

          -  have an indwelling central venous catheter

          -  have received an analgesic or sedative medication in the previous four hours prior to
             enrollment

          -  have an underlying chronic disorder that would impact on their ability to express
             distress when in painful or otherwise anxiety-provoking situations

          -  known hypersensitivity to lidocaine or any component of the formulation

          -  hypersensitivity to another local anesthetic of the amide type

          -  Adam-Stokes syndrome

          -  severe degrees of SA, AV, or intraventricular heart block

          -  allergy to corn-related products

          -  contraindication to propofol