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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Akron Children's Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00786916
First received: November 5, 2008
Last updated: January 21, 2011
Last verified: January 2011
  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: Single Group 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 ]

Estimated Enrollment: 60
Study Start Date: February 2008
Estimated Study Completion Date: January 2011
Estimated 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
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 painfulr 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Norman Christopher, M.D., Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00786916     History of Changes
Other Study ID Numbers: 080209
Study First Received: November 5, 2008
Last Updated: January 21, 2011
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
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 20, 2014