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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A

Saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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.

Group B

Lidocaine 0.25 mg/kg

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

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.

Group C

Lidocaine 0.5 mg/kg

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

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.

Interventions

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lidocaine

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 Type DRUG

lidocaine

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.

Intervention Type DRUG

normal saline

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes