Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation

Akron Children's Hospital109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

109

Conditions

Pain

Interventions

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.

lidocaineDRUG

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.

lidocaineDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Maximal Pain/Discomfort

FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where "0" represented "no pain" and 100 (the furthest point to the left) represented the worst pain ever.

Time frame: during initial 3 minute propofol infusion