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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael D. Reed, Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00786916
First received: November 5, 2008
Last updated: February 26, 2015
Last verified: February 2015
  Purpose
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 Intervention Phase
Pain
Drug: normal saline
Drug: lidocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Intravenous Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Procedural Sedation

Resource links provided by NLM:


Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • Maximal Pain/Discomfort [ Time Frame: during initial 3 minute propofol infusion ] [ Designated as safety issue: No ]
    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.


Enrollment: 109
Study Start Date: February 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   2 Years to 7 Years   (Child)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Michael D. Reed, Pharm.D., Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00786916     History of Changes
Other Study ID Numbers: 080209 
Study First Received: November 5, 2008
Results First Received: January 23, 2013
Last Updated: February 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 21, 2016