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

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ClinicalTrials.gov Identifier: NCT00786916
Recruitment Status : Completed
First Posted : November 6, 2008
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Michael D. Reed, Akron Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: normal saline Drug: lidocaine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Intravenous Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Procedural Sedation
Study Start Date : February 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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Arm Intervention/treatment
Placebo Comparator: Group A
Saline
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.

Active Comparator: Group B
Lidocaine 0.25 mg/kg
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.

Active Comparator: Group C
Lidocaine 0.5 mg/kg
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 0.5 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.




Primary Outcome Measures :
  1. Maximal Pain/Discomfort [ Time Frame: during initial 3 minute propofol infusion ]
    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.



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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786916


Locations
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: Norman C Christopher, MD Akron Children's Hospital

Responsible Party: Michael D. Reed, Pharm.D., Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00786916     History of Changes
Other Study ID Numbers: 080209
First Posted: November 6, 2008    Key Record Dates
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015

Keywords provided by Michael D. Reed, Akron Children's Hospital:
pain
propofol
lidocaine
sedation
pediatric

Additional relevant MeSH terms:
Lidocaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General