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

Study Overview
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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.

Official Title
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Efficacy of Intravenous Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Procedural Sedation

Conditions
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Pain

Intervention / Treatment
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* Drug: normal saline
* Drug: lidocaine
* Drug: lidocaine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A<br>Saline | Drug: normal saline<br>* 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.<br>|
| Active Comparator: Group B<br>Lidocaine 0.25 mg/kg | Drug: lidocaine<br>* 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.<br>|
| Active Comparator: Group C<br>Lidocaine 0.5 mg/kg | Drug: lidocaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during initial 3 minute propofol infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, propofol, lidocaine, sedation, pediatric